Trial Outcomes & Findings for Pharmacogenetics of Disulfiram for Cocaine (NCT NCT00149630)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

93 participants

Primary outcome timeframe

Thrice weekly, baseline through week 14.

Results posted on

2017-03-15

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	34	40
Overall Study COMPLETED	26	35
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Incarceration	2	0
Overall Study Treatment Programs	4	5
Overall Study Adverse Event	2	0

Baseline Characteristics

Pharmacogenetics of Disulfiram for Cocaine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disulfiram n=34 Participants 250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.	Placebo n=40 Participants Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.5 years STANDARD_DEVIATION 10.5 • n=5 Participants	40 years STANDARD_DEVIATION 10 • n=7 Participants	38.75 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	40 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: Thrice weekly, baseline through week 14.

Population: 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.

Outcome measures

Outcome measures
Measure	Placebo CC n=21 Participants Subjects who received placebo with a genotype of CC.	Placebo CT/TT n=19 Participants Subjects who received placebo with genotype CT/TT.	Disulfiram CC n=17 Participants Subjects who received Disulfiram with genotype CC.	Disulfiram CT/TT n=17 Participants Subjects who received Disulfiram with genotype CT/TT.
Urine Toxicology for Cocaine.	84 % cocaine + urines over 2 week blocks Standard Error 5	68 % cocaine + urines over 2 week blocks Standard Error 5	56 % cocaine + urines over 2 week blocks Standard Error 5	67 % cocaine + urines over 2 week blocks Standard Error 5

SECONDARY outcome

Timeframe: 12 weeks

Population: 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.

Treatment retention for full 12 weeks of study.

Outcome measures

Outcome measures
Measure	Placebo CC n=34 Participants Subjects who received placebo with a genotype of CC.	Placebo CT/TT n=40 Participants Subjects who received placebo with genotype CT/TT.	Disulfiram CC Subjects who received Disulfiram with genotype CC.	Disulfiram CT/TT Subjects who received Disulfiram with genotype CT/TT.
Retention by Treatment Condition.	77 % of subjects who complete 12 wks study	87 % of subjects who complete 12 wks study	—	—

Adverse Events

Disulfarim

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Disulfarim n=34 participants at risk 250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.	Placebo n=40 participants at risk Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
Renal and urinary disorders Reduced sexual functioning.	2.9% 1/34 • Number of events 1	0.00% 0/40
Psychiatric disorders Suicide gesture.	0.00% 0/34	2.5% 1/40 • Number of events 1
Vascular disorders Arm numbness.	2.9% 1/34 • Number of events 1	0.00% 0/40
Vascular disorders Arm numbness and back rash.	2.9% 1/34 • Number of events 1	0.00% 0/40

Additional Information

Thomas R. Kosten, M.D.

Baylor College of Medicine

Phone: (713) 794-7032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place