Pharmacogenetics of Disulfiram for Cocaine

This study has been completed.
Sponsor:
Collaborators:
Yale University
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00149630
First received: September 6, 2005
Last updated: November 27, 2012
Last verified: November 2012
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cocaine Dependence
Opioid Dependence
Interventions: Drug: Disulfiram
Drug: Methadone
Behavioral: CBT
Other: Lactose

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The 74 opioid and cocaine dependent subjects were drawn from a sample of 93 candidates who entered into a 2-week screening period for stabilization on methadone maintenance between 2005 and 2006 at Yale University (n=40) and then from between 2006 and 2008 at Baylor College of Medicine (n=53).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eleven subjects were excluded prior to randomization because they did not have at least one urine toxicology positive for opiates or cocaine metabolites during the two-week screening. Another eight subjects were lost to follow-up prior to randomization.

Reporting Groups
  Description
Disulfiram 250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
Placebo Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.

Participant Flow:   Overall Study
    Disulfiram     Placebo  
STARTED     34     40  
COMPLETED     26     35  
NOT COMPLETED     8     5  
Incarceration                 2                 0  
Treatment Programs                 4                 5  
Adverse Event                 2                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Disulfiram 250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
Placebo Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
Total Total of all reporting groups

Baseline Measures
    Disulfiram     Placebo     Total  
Number of Participants  
[units: participants]
  34     40     74  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     34     40     74  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.5  ± 10.5     40  ± 10     38.75  ± 10  
Gender  
[units: participants]
     
Female     10     12     22  
Male     24     28     52  
Region of Enrollment  
[units: participants]
     
United States     34     40     74  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Urine Toxicology for Cocaine.   [ Time Frame: Thrice weekly, baseline through week 14. ]

2.  Secondary:   Retention by Treatment Condition.   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
The sample size is small for this genetic association study, and larger replications of this preliminary study are needed. Most cocaine abusers are not also opioid dependent, which limits generalization of findings.  


Results Point of Contact:  
Name/Title: Thomas R. Kosten, M.D.
Organization: Baylor College of Medicine
phone: (713) 794-7032
e-mail: kosten@bcm.edu


No publications provided


Responsible Party: Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00149630     History of Changes
Other Study ID Numbers: NIDA-18197-2, P50DA018197-02, P50-DA18197-02, DPMC
Study First Received: September 6, 2005
Results First Received: October 22, 2012
Last Updated: November 27, 2012
Health Authority: United States: Federal Government