Trial Outcomes & Findings for A Study of the Relationship Between Disulfiram and Cocaine Self-administration. (NCT NCT00729300)

NCT ID: NCT00729300

Last Updated: 2023-07-19

Results Overview

The reinforcing effects of cocaine were determined using a self-administration procedure in which subjects choose to take previously sampled doses of cocaine or cash of increasing monetary value. The mean number of cocaine choices across each drug condition (i.e., placebo and disulfiram) is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: 4 days
• Results posted on: 2023-07-19

Participant Flow

Participant milestones

Measure	Placebo Placebo placebo: placebo daily	Disulfiram Treatment Group disulfiram disulfiram: 250mg daily
Overall Study STARTED	26	26
Overall Study COMPLETED	17	17
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of the Relationship Between Disulfiram and Cocaine Self-administration.

Baseline characteristics by cohort

Measure	Placebo Group n=17 Participants Placebo placebo: placebo daily	Disulfiram Treatment Group n=17 Participants disulfiram disulfiram: 250mg daily	Total n=34 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	17 Participants n=5 Participants	17 Participants n=7 Participants	34 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	41.41 years STANDARD_DEVIATION 1.61 • n=5 Participants	41.41 years STANDARD_DEVIATION 1.61 • n=7 Participants	41.41 years STANDARD_DEVIATION 1.61 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 days

Population: Only data from study completers was considered

The reinforcing effects of cocaine were determined using a self-administration procedure in which subjects choose to take previously sampled doses of cocaine or cash of increasing monetary value. The mean number of cocaine choices across each drug condition (i.e., placebo and disulfiram) is reported.

Outcome measures

Measure	Placebo n=170 cocaine choices Placebo placebo: placebo daily	Disulfiram Treatment Group n=170 cocaine choices disulfiram disulfiram: 250mg daily
Cocaine Self-administration	2.5 cocaine choices/participant Standard Error 0.5	4.8 cocaine choices/participant Standard Error 0.8

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Disulfiram

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christopher Verrico

Baylor College of Medicine

Phone: 713-791-1313

Email: verrico@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place