Trial Outcomes & Findings for Vigabatrin for Cocaine and Alcohol Dependence (NCT NCT01335867)

Results Overview

The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

last 3 weeks of the trial

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Vigabatrin Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks	Placebo Placebo: Placebo pills
Overall Study STARTED	16	16
Overall Study COMPLETED	9	12
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vigabatrin for Cocaine and Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vigabatrin n=16 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks	Placebo n=16 Participants Placebo: Placebo pills	Total n=32 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	16 Participants n=5 Participants	16 Participants n=7 Participants	32 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	46 years STANDARD_DEVIATION 7.97 • n=5 Participants	48 years STANDARD_DEVIATION 6.81 • n=7 Participants	47 years STANDARD_DEVIATION 7.35 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: last 3 weeks of the trial

The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.

Outcome measures

Outcome measures
Measure	Vigabatrin n=16 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks	Placebo n=16 Participants Placebo: Placebo pills
Number of Participants With a Reduction in Cocaine Use	0 participants	2 participants

PRIMARY outcome

Timeframe: 8 weeks

The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.

Outcome measures

Outcome measures
Measure	Vigabatrin n=16 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks	Placebo n=16 Participants Placebo: Placebo pills
Proportion of Heavy Drinking Days	.26 proportion of heavy drinking days Standard Deviation .18	.20 proportion of heavy drinking days Standard Deviation .25

SECONDARY outcome

Timeframe: 8 weeks

Population: subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.

Measures of cocaine craving at the end of the trial will be measured using the Brief Substance Craving Ccale. Craving intensity + Craving frequency + Craving Duration each measured on a 4 point scale. Sum of the three scales was overall craving composite. Higher numbers meaning greater craving. Maximum score 12 minimum 0.

Outcome measures

Outcome measures
Measure	Vigabatrin n=9 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks	Placebo n=8 Participants Placebo: Placebo pills
Measures of Cocaine Craving	1.44 score on a scale Standard Deviation 2.3	0.38 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 8 weeks

Number of subjects in each group rated as improved or very much improved at the end of the trial

Outcome measures

Outcome measures
Measure	Vigabatrin n=16 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks	Placebo n=16 Participants Placebo: Placebo pills
Disease Severity and Improvement	5 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.

Measure of cocaine withdrawal severity will include Cocaine Selective Severity Assessment scores. Minimum score is 0 Maximum score is 119 Higher score is indicative of worse cocaine withdrawal symptoms.

Outcome measures

Outcome measures
Measure	Vigabatrin n=10 Participants Vigabatrin: Vigabatrin escalated to 3 grams daily for 12 weeks	Placebo n=11 Participants Placebo: Placebo pills
Cocaine Withdrawal Severity	8.0 score on a scale Standard Deviation 8.1	6.5 score on a scale Standard Deviation 6.8

Adverse Events

Vigabatrin

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vigabatrin n=16 participants at risk Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks	Placebo n=16 participants at risk Placebo: Placebo pills
Gastrointestinal disorders Nausea	12.5% 2/16	0.00% 0/16
General disorders Headache	12.5% 2/16	0.00% 0/16
General disorders Dry Mouth	12.5% 2/16	0.00% 0/16
Musculoskeletal and connective tissue disorders Back Pain	12.5% 2/16	0.00% 0/16
Respiratory, thoracic and mediastinal disorders URI Symptoms	12.5% 2/16	18.8% 3/16
Skin and subcutaneous tissue disorders Nasal Congestion	0.00% 0/16	12.5% 2/16
Musculoskeletal and connective tissue disorders Sore Knees	0.00% 0/16	12.5% 2/16
Gastrointestinal disorders Vomiting	0.00% 0/16	12.5% 2/16
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/16	12.5% 2/16
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/16	12.5% 2/16

Additional Information

Kyle M. Kampman, M.D.

University of Pennsylvania Treatment Research Center

Phone: 215 746 2764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place