Trial Outcomes & Findings for D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals (NCT NCT00780442)

NCT ID: NCT00780442

Last Updated: 2018-07-06

Results Overview

Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating "Not at all" and 10 indicating "Extremely".

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: Immediately following cue exposure
• Results posted on: 2018-07-06

Participant Flow

Participant milestones

Measure	D-cycloserine Participants received DCS prior to cocaine cue exposure sessions.	Placebo Participants received placebo prior to cocaine cue exposure sessions.
Overall Study STARTED	12	15
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-Cycloserine and Cue Exposure in Cocaine-Dependent Individuals

Baseline characteristics by cohort

Measure	D-cycloserine n=12 Participants Participants received DCS prior to cocaine cue exposure sessions.	Placebo n=15 Participants Participants received placebo prior to cocaine cue exposure sessions.	Total n=27 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	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following cue exposure

Population: Cocaine dependent individuals

Scale assess cocaine craving following cocaine cue exposure after two administrations of DCS. Subjects rate craving on a scale from 0-10 with 0 indicating "Not at all" and 10 indicating "Extremely".

Outcome measures

Measure	D-cycloserine n=12 Participants Participants received DCS prior to cocaine cue exposure sessions.	Placebo n=15 Participants Participants received placebo prior to cocaine cue exposure sessions.
Cocaine Craving Scale	4.33 Units on a scale Standard Deviation 3.98	3.13 Units on a scale Standard Deviation 2.92

Adverse Events

D-cycloserine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Kimber L. Price

Medical University of South Carolina

Phone: 843-792-4847

Email: pricekl@musc.edu

Results disclosure agreements

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