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Pharmacogenetics of Disulfiram for Cocaine (Disulfiram)

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
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: February 4, 2017
Last verified: February 2017
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cocaine Dependence
Opioid Dependence
Interventions: Drug: Disulfiram
Drug: Methadone
Behavioral: CBT
Other: Lactose

  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
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
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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
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 
Overall Participants Analyzed 
[Units: Participants]
 34   40   74 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34 100.0%      40 100.0%      74 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.5  (10.5)   40  (10)   38.75  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  29.4%      12  30.0%      22  29.7% 
Male      24  70.6%      28  70.0%      52  70.3% 
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


  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
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.


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


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

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 ( U.S. NIH Grant/Contract )
Study First Received: September 6, 2005
Results First Received: October 22, 2012
Last Updated: February 4, 2017