Trial Outcomes & Findings for D-Cycloserine Facilitation of Cocaine - Cue Extinction (NCT NCT00759473)

Last Updated: 2016-04-13

Results Overview

Average of participants' subjective measures of craving immediately following cue exposure at the one-week follow-up session. Participants rated craving on a 10 point analog scale ranging from 0 (not at all) to 10 (extremely).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

two weeks

Results posted on

2016-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	DCS/DCS/DCS/ Placebo Participants were assigned to receive 50 mg of d-cycloserine (DCS) for each of 3 cue exposure sessions and a placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	Placebo/Placebo/Placebo/Placebo Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	DCS/ Placebo/DCS/Placebo Participants were assigned to receive 50 mg of d-cycloserine (DCS) at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	DCS/DCS/Placebo Participants were assigned to receive 50 mg of d-cycloserine (DCS) at 2 cue cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.	Placebo/Placebo/Placebo Participants were assigned to receive placebo at 2 cue exposure sessions, and at the one-week follow-up session. Participants also received cognitive skills training. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.
Overall Study STARTED	10	10	12	23	24
Overall Study COMPLETED	10	10	12	23	24
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

D-Cycloserine Facilitation of Cocaine - Cue Extinction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DCS/DCS/DCS/Placebo n=10 Participants Participants were assigned to receive 50 mg of DCS for each of 3 cue exposure sessions and a placebo at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	Placebo/Placebo/Placebo/Placebo n=10 Participants Participants were assigned to receive a placebo for each of 3 cue exposure sessions and at the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	DCS/ Placebo/DCS/Placebo n=12 Participants Participants were assigned to receive 50 mg of DCS at the 1st and 3rd cue sessions and placebo at the 2nd cue session and the one-week follow-up session.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities.	DCS /DCS/Placebo n=23 Participants Participants were assigned to receive 50 mg of DCS at 2 cue exposure sessions, and placebo at the one-week follow-up session. During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.	Placebo/Placebo/Placebo n=24 Participants Participants were assigned to receive placebo at 2 cue expsosure sessions, and at the one-week follow-up session. Participants also received cognitive skills training.During cue exposure sessions, participants were asked to handle cocaine cues such as simulated crack, powder, and pipes while listening to an imagery script, and then they watched video footage of cocaine-related activities. Cue exposure was accompanied by instructions on how to cope with craving.	Total n=79 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	23 Participants n=4 Participants	24 Participants n=21 Participants	79 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	43.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	45.1 years STANDARD_DEVIATION 8.4 • n=7 Participants	43.1 years STANDARD_DEVIATION 5.9 • n=5 Participants	49.1 years STANDARD_DEVIATION 8.8 • n=4 Participants	44.4 years STANDARD_DEVIATION 8.7 • n=21 Participants	45.5 years STANDARD_DEVIATION 8.7 • n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	17 Participants n=10 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants	21 Participants n=21 Participants	62 Participants n=10 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	12 participants n=5 Participants	23 participants n=4 Participants	24 participants n=21 Participants	79 participants n=10 Participants

PRIMARY outcome

Timeframe: two weeks

Population: Data of participants who completed all cue exposure sessions and the one-week follow-up were analyzed.