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Trial record 28 of 46 for:    disulfiram

Pharmacogenetics of Disulfiram for Cocaine (Disulfiram)

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ClinicalTrials.gov Identifier: NCT00149630
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : December 28, 2012
Last Update Posted : March 15, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Yale University
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine

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
Enrollment 93
Recruitment Details 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 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.
Arm/Group Title Disulfiram Placebo
Hide Arm/Group Description 250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15. Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
Period Title: Overall Study
Started 34 40
Completed 26 35
Not Completed 8 5
Reason Not Completed
Incarceration             2             0
Treatment Programs             4             5
Adverse Event             2             0
Arm/Group Title Disulfiram Placebo Total
Hide Arm/Group Description 250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15. Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15. Total of all reporting groups
Overall Number of Baseline Participants 34 40 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 40 participants 74 participants
37.5  (10.5) 40  (10) 38.75  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 40 participants 74 participants
Female
10
  29.4%
12
  30.0%
22
  29.7%
Male
24
  70.6%
28
  70.0%
52
  70.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 40 participants 74 participants
34 40 74
1.Primary Outcome
Title Urine Toxicology for Cocaine.
Hide Description [Not Specified]
Time Frame Thrice weekly, baseline through week 14.
Hide Outcome Measure Data
Hide Analysis Population Description
74 cocaine and opioid-codependent (DSM-V) subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduces DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.
Arm/Group Title Placebo CC Placebo CT/TT Disulfiram CC Disulfiram CT/TT
Hide Arm/Group Description:
Subjects who received placebo with a genotype of CC.
Subjects who received placebo with genotype CT/TT.
Subjects who received Disulfiram with genotype CC.
Subjects who received Disulfiram with genotype CT/TT.
Overall Number of Participants Analyzed 21 19 17 17
Mean (Standard Error)
Unit of Measure: % cocaine + urines over 2 week blocks
84  (5) 68  (5) 56  (5) 67  (5)
2.Secondary Outcome
Title Retention by Treatment Condition.
Hide Description Treatment retention for full 12 weeks of study.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
74 cocaine and opioid-codependent(DSM-V)subjects were stabilized on methadone for 2 weeks and subsequently randomized into disulfiram (250 mg/day, n=34) and placebo groups (n=40) for 10 weeks. We genotyped the DBH gene polymorphism that reduced DBH enzyme levels and evaluated its role for increasing cocaine free urines with disulfiram.
Arm/Group Title Disulfiram Placebo
Hide Arm/Group Description:
250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
Overall Number of Participants Analyzed 34 40
Measure Type: Number
Unit of Measure: % of subjects who complete 12 wks study
77 87
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Disulfarim Placebo
Hide Arm/Group Description 250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15. Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
All-Cause Mortality
Disulfarim Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Disulfarim Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Disulfarim Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/34 (8.82%)      1/40 (2.50%)    
Psychiatric disorders     
Suicide gesture. * [1]  0/34 (0.00%)  0 1/40 (2.50%)  1
Renal and urinary disorders     
Reduced sexual functioning. * [2]  1/34 (2.94%)  1 0/40 (0.00%)  0
Vascular disorders     
Arm numbness. * [3]  1/34 (2.94%)  1 0/40 (0.00%)  0
Arm numbness and back rash. * [4]  1/34 (2.94%)  1 0/40 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
One placebo patient made suicidal gesture of superficially cutting his wrist but was not hospitalized and completed 12 weeks.
[2]
One disulfiram patient left the study for reduced sexual functioning but this was considered as related to the methadone.
[3]
Disulfiram patient had arm numbness that resolved spontaneously during the trial without any changes in medication. Patient completed 12 weeks of trial.
[4]
Disulfiram patient had arm numbness and back rash and left at Week 6.
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.
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
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 )
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: October 22, 2012
Results First Posted: December 28, 2012
Last Update Posted: March 15, 2017