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Effectiveness of Extended Treatments for Drug Dependence (ETDD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00685659
First Posted: May 28, 2008
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
Results First Submitted: February 15, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment as Usual

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

TMAC

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

TMAC Plus

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


Participant Flow:   Overall Study
    Treatment as Usual   TMAC   TMAC Plus
STARTED   108   106   107 
COMPLETED   77   81   92 
NOT COMPLETED   31   25   15 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment as Usual

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

TMAC

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

TMAC Plus

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 Total of all reporting groups

Baseline Measures
   Treatment as Usual   TMAC   TMAC Plus   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   106   107   321 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.9  (8.0)   43.3  (7.8)   43.4  (6.48)   43.2  (7.43) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   108   106   107   321 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Abstinence   [ Time Frame: 3 month follow up ]

2.  Primary:   Abstinence   [ Time Frame: 6 month follow up ]

3.  Primary:   Abstinence   [ Time Frame: 9 month follow up ]

4.  Primary:   Abstinence   [ Time Frame: 12 month follow up ]

5.  Primary:   Abstinence   [ Time Frame: 18 month follow up ]

6.  Primary:   Abstinence   [ Time Frame: 24 month follow up ]

7.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 3 month follow up ]

8.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 6 month follow up ]

9.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 9 month follow up ]

10.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 12 month follow up ]

11.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 18 month follow up ]

12.  Primary:   Cocaine Urine Toxicology   [ Time Frame: 24 month follow up ]

13.  Primary:   Comparison Across Groups in Societal Costs   [ Time Frame: 24 months ]

14.  Primary:   Net Saving/Spending Comparisons Across Groups From Provider Perspective   [ Time Frame: 24 months ]

15.  Primary:   Net Comparisons of Savings and Spendings Across Groups From Societal Perspective   [ Time Frame: 24 months ]

16.  Primary:   Percent Days Cocaine Use   [ Time Frame: 3 months (approximately study days 1 - 90) ]

17.  Primary:   Percent Days Cocaine Use   [ Time Frame: 6 months (approproximately study days 91 - 180) ]

18.  Primary:   Percent Days Cocaine Use   [ Time Frame: 9 months (approximately study days 181 - 270) ]

19.  Primary:   Percent Days Cocaine Use   [ Time Frame: 12 months (approximately study days 271 - 365) ]

20.  Primary:   Percent Days Cocaine Use   [ Time Frame: 18 months (approximately study days 366 - 546) ]

21.  Primary:   Percent Days Cocaine Use   [ Time Frame: 24 months (approximately study days 547 - 730) ]

22.  Primary:   Percent Days Abstinent   [ Time Frame: 3 months (approximately study days 1 - 90) ]

23.  Primary:   Percent Days Abstinent   [ Time Frame: 6 months (approximately study days 91 - 180) ]

24.  Primary:   Percent Days Abstinent   [ Time Frame: 9 months (approximately study days 181 - 270) ]

25.  Primary:   Percent Days Abstinent   [ Time Frame: 12 months (approximately study days 271 - 365) ]

26.  Primary:   Percent Days Abstinent   [ Time Frame: 18 months (approximately days 366 - 546) ]

27.  Primary:   Percent Days Abstinent   [ Time Frame: 24 months (approximately study days 547 - 730) ]

28.  Secondary:   Participation in Protocol   [ Time Frame: 24 months ]

29.  Secondary:   HIV Sex Risk Score   [ Time Frame: 12 months ]

30.  Secondary:   HIV Sex Risk Score   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: jimrache@mail.med.upenn.edu


Publications of Results:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00685659     History of Changes
Other Study ID Numbers: 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