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Effectiveness of Extended Treatments for Drug Dependence (ETDD)

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ClinicalTrials.gov Identifier: NCT00685659
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : December 14, 2016
Last Update Posted : August 7, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Other: Intensive Outpatient Treatment
Other: Adaptive telephone-based counseling
Other: Adaptive telephone-based counseling plus incentives
Enrollment 332
Recruitment Details We enrolled 332, but 11 of those were pilot participants assigned to receive the Telephone Monitoring and Counseling plus vouchers. They were not randomly assigned participants and their data was not included in the final analyses.
Pre-assignment Details  
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Period Title: Overall Study
Started 108 106 107
Completed 77 81 92
Not Completed 31 25 15
Arm/Group Title Treatment as Usual TMAC TMAC Plus Total
Hide Arm/Group Description

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Total of all reporting groups
Overall Number of Baseline Participants 108 106 107 321
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 106 participants 107 participants 321 participants
42.9  (8.0) 43.3  (7.8) 43.4  (6.48) 43.2  (7.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 106 participants 107 participants 321 participants
Female
26
  24.1%
26
  24.5%
24
  22.4%
76
  23.7%
Male
82
  75.9%
80
  75.5%
83
  77.6%
245
  76.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 106 participants 107 participants 321 participants
Hispanic or Latino
2
   1.9%
7
   6.6%
3
   2.8%
12
   3.7%
Not Hispanic or Latino
105
  97.2%
99
  93.4%
104
  97.2%
308
  96.0%
Unknown or Not Reported
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 106 participants 107 participants 321 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
97
  89.8%
89
  84.0%
98
  91.6%
284
  88.5%
White
8
   7.4%
10
   9.4%
6
   5.6%
24
   7.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   2.8%
7
   6.6%
3
   2.8%
13
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 108 participants 106 participants 107 participants 321 participants
108 106 107 321
1.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 3 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents that number of people we reached for three month follow up evaluation.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 96 97 96
Measure Type: Number
Unit of Measure: participants
45 57 45
2.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents that number of participants we reached for 6 month follow up evaluation.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 95 95 95
Measure Type: Number
Unit of Measure: participants
43 44 42
3.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 9 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants we were able to reach for the 9 month follow up evaluation.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 91 91 91
Measure Type: Number
Unit of Measure: participants
43 44 39
4.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 12 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants we were able to reach at the 12 month follow up for evaluation.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 89 90 90
Measure Type: Number
Unit of Measure: participants
33 39 42
5.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 18 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants we were able to reach for the 18 month follow up.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 77 79 83
Measure Type: Number
Unit of Measure: participants
30 27 34
6.Primary Outcome
Title Abstinence
Hide Description Abstinence as reported on Addiction Severity Index, Timeline Follow up, and as tested on the urine drug screen. Measure was created as such: if on ASI the participant reported no use, and on the TLFB the participant reported no use, and on the urine drug screen there was no substances detected, then the participant is considered abstinent. If there is use indicated on any one or all of those items (ASI, TLFB, UDS) then the participant is not abstinent.
Time Frame 24 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants we were able to reach for 24 month follow up.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 59 64 68
Measure Type: Number
Unit of Measure: participants
20 28 24
7.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 3 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 3.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 89 76 83
Measure Type: Number
Unit of Measure: proportion of participants positive
0.31 0.22 0.20
8.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 6 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 6.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 82 76 83
Measure Type: Number
Unit of Measure: proportion of participants positive
0.26 0.24 0.28
9.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 9 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 9.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 74 69 78
Measure Type: Number
Unit of Measure: proportion of participants positive
0.30 0.25 0.29
10.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 12 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 12.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 76 73 77
Measure Type: Number
Unit of Measure: proportion of participants positive
0.37 0.27 0.27
11.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 18 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 18.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 67 72 80
Measure Type: Number
Unit of Measure: proportion of participants positive
0.33 0.29 0.24
12.Primary Outcome
Title Cocaine Urine Toxicology
Hide Description Positive cocaine test of urine
Time Frame 24 month follow up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The N analyzed represents the number of participants for whom we had UDS results in month 24.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 69 80 75
Measure Type: Number
Unit of Measure: proportion of participants positive
038 0.26 0.35
13.Primary Outcome
Title Comparison Across Groups in Societal Costs
Hide Description Total savings/spending calculated as the monetary value of days of illegal activity, days experiencing medical problems, days experiencing psychiatric problems, and days in jail captured with the ASI. Presented in 2008 dollars.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 108 106 107
Mean (Standard Deviation)
Unit of Measure: US Dollars
-1545  (23195) 1564  (10997) -191  (20514)
14.Primary Outcome
Title Net Saving/Spending Comparisons Across Groups From Provider Perspective
Hide Description Savings minus intervention costs. Presented in 2008 dollars.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 108 106 107
Mean (Standard Deviation)
Unit of Measure: US Dollars
-1545  (23195) 1222  (11000) -750  (20477)
15.Primary Outcome
Title Net Comparisons of Savings and Spendings Across Groups From Societal Perspective
Hide Description Savings minus intervention costs. Presented in 2008 dollars.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 108 106 107
Mean (Standard Deviation)
Unit of Measure: US Dollars
-1545  (23195) 838  (11018) -1497  (20414)
16.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 3 months (approximately study days 1 - 90)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 99 97 97
Mean (Standard Error)
Unit of Measure: percentage of days
4.50  (1.53) 4.25  (1.56) 5.91  (1.80)
17.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 6 months (approproximately study days 91 - 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 98 91 94
Mean (Standard Error)
Unit of Measure: percentage of days
6.60  (1.98) 7.01  (2.14) 11.66  (2.47)
18.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 9 months (approximately study days 181 - 270)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 93 87 91
Mean (Standard Error)
Unit of Measure: percentage of days
6.96  (2.19) 8.23  (2.22) 5.43  (1.81)
19.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 12 months (approximately study days 271 - 365)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 91 87 91
Mean (Standard Error)
Unit of Measure: percentage of days
5.58  (1.82) 8.88  (2.38) 7.89  (2.37)
20.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 18 months (approximately study days 366 - 546)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 81 82 84
Mean (Standard Error)
Unit of Measure: percentage of days
5.13  (1.66) 6.97  (1.98) 5.18  (1.48)
21.Primary Outcome
Title Percent Days Cocaine Use
Hide Description Percent of days during the follow up that there was any cocaine use
Time Frame 24 months (approximately study days 547 - 730)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 77 82 80
Mean (Standard Error)
Unit of Measure: percentage of days
9.80  (2.69) 6.14  (2.06) 6.01  (1.77)
22.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 3 months (approximately study days 1 - 90)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 99 97 97
Mean (Standard Error)
Unit of Measure: percentage of days
94.01  (1.66) 89.85  (2.45) 92.70  (1.85)
23.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 6 months (approximately study days 91 - 180)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 98 91 94
Mean (Standard Error)
Unit of Measure: percentage of days
90.20  (2.23) 89.44  (2.41) 85.61  (2.75)
24.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 9 months (approximately study days 181 - 270)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 93 87 91
Mean (Standard Error)
Unit of Measure: percentage of days
88.16  (2.75) 87.94  (2.64) 91.79  (2.08)
25.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 12 months (approximately study days 271 - 365)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 91 87 91
Mean (Standard Error)
Unit of Measure: percentage of days
88.91  (2.55) 87.53  (2.68) 89.60  (2.50)
26.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 18 months (approximately days 366 - 546)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 81 82 84
Mean (Standard Error)
Unit of Measure: percentage of days
86.40  (3.03) 88.58  (2.55) 90.56  (1.96)
27.Primary Outcome
Title Percent Days Abstinent
Hide Description Percent of days during the follow up that participant was abstinent from Alcohol and Cocaine
Time Frame 24 months (approximately study days 547 - 730)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at three months for whom complete Time Line Follow Back data was available.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 77 82 80
Mean (Standard Error)
Unit of Measure: percentage of days
84.00  (3.45) 88.88  (2.69) 89.66  (2.42)
28.Secondary Outcome
Title Participation in Protocol
Hide Description Percent available sessions completed
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in TAU did not receive telephone counseling so were not included in these analyses. N's for TMAC and TMAC Plus represent participants who completed orientation.
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 0 69 82
Mean (Standard Deviation)
Unit of Measure: percentage of sessions
38.8  (31.9) 67.1  (30.7)
29.Secondary Outcome
Title HIV Sex Risk Score
Hide Description Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at 12 months for whom we have a completed RAB (Risk Assessment Battery).
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 79 74 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.65) 2.8  (2.10) 2.7  (2.23)
30.Secondary Outcome
Title HIV Sex Risk Score
Hide Description Risk score from RAB: Risk Assessment Battery. The RAB is a 41 - item self report developed to study the transmission of HIV. The Risk Assessment Battery generates a drug-risk score and a sex-risk score. For this study, the sex-risk score was used as the outcome measure of sexual behavior that is associated with HIV transmission. The sex-risk score ranges from 0 to 18, with 0 denoting no sex-risk and 18 denoting highest sex-risk. Previous research among drug using populations have found a sex-risk score mean of 6.2.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
N's represent the participants at 24 months for whom we have a completed RAB (Risk Assessment Battery).
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description:

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

Overall Number of Participants Analyzed 70 78 77
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (2.45) 3  (2.74) 2.7  (2.56)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment as Usual TMAC TMAC Plus
Hide Arm/Group Description

Control condition that consists of treatment as usual, which is Intensive Outpatient Treatment (about 3 months long)

Intensive Outpatient Treatment: 9 hours of group counseling per week for 2-3 months

Adaptive telephone-based counseling

Adaptive telephone-based counseling: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm is included

Adaptive telephone-based counseling, plus incentives

Adaptive telephone-based counseling plus incentives: In addition to IOP, patients receive telephone counseling calls, in which risk level is assessed and coping skills intervention delivered to address risk areas. Adaptive stepped care algorithm and monetary incentives for participation are included

All-Cause Mortality
Treatment as Usual TMAC TMAC Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/108 (1.85%)   1/106 (0.94%)   1/107 (0.93%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment as Usual TMAC TMAC Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/106 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment as Usual TMAC TMAC Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/106 (0.00%)   0/107 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James R. McKay, Ph.D.
Organization: University of Pennsylvania
Phone: 215-746-7704
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00685659     History of Changes
Other Study ID Numbers: R01DA020623 ( U.S. NIH Grant/Contract )
R01DA020623 ( U.S. NIH Grant/Contract )
First Submitted: May 23, 2008
First Posted: May 28, 2008
Results First Submitted: February 15, 2016
Results First Posted: December 14, 2016
Last Update Posted: August 7, 2017