Effectiveness of Extended Treatments for Drug Dependence (ETDD)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00685659
First received: May 23, 2008
Last updated: October 20, 2016
Last verified: October 2016
Results First Received: February 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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) 
Gender 
[Units: Participants]
       
Female   26   26   24   76 
Male   82   80   83   245 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   2   7   3   12 
Not Hispanic or Latino   105   99   104   308 
Unknown or Not Reported   1   0   0   1 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   97   89   98   284 
White   8   10   6   24 
More than one race   0   0   0   0 
Unknown or Not Reported   3   7   3   13 
Region of Enrollment 
[Units: Participants]
       
United States   108   106   107   321 


  Outcome Measures

1.  Primary:   Abstinence From Cocaine, Alcohol, and Other Drugs.   [ Time Frame: at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups ]

2.  Secondary:   Percent Days Cocaine Use   [ Time Frame: at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Cocaine Urine Toxicology Results   [ Time Frame: at baseline, and 3, 6, 9, 12, 18, and 24 mo follow-ups ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00685659     History of Changes
Other Study ID Numbers: R01DA020623 ( US NIH Grant/Contract Award Number )
Study First Received: May 23, 2008
Results First Received: February 15, 2016
Last Updated: October 20, 2016