Trial · NCT01335867

Vigabatrin for Cocaine and Alcohol Dependence

NCT01335867, Phase 2, Terminated, University of Pennsylvania; results first posted 2015-06-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vigabatrin for Cocaine and Alcohol Dependence. Trials, record NCT01335867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01335867

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vigabatrin for Cocaine and Alcohol Dependence
NCT number: NCT01335867
Status: Terminated
Phases: Phase 2
Enrollment: 32 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Alcoholism, Cocaine Dependence
Interventions: Vigabatrin, Placebo
First posted: 2011-04-14
Last updated: 2019-09-06
Results first posted: 2015-06-12

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With a Reduction in Cocaine Use	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.
Primary	Proportion of Heavy Drinking Days	8 weeks	The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.
Secondary	Measures of Cocaine Craving	8 weeks	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.
Secondary	Disease Severity and Improvement	8 weeks	Number of subjects in each group rated as improved or very much improved at the end of the trial
Secondary	Cocaine Withdrawal Severity	8 weeks	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Reduction in Cocaine Use	last 3 weeks of the trial		participants	NUMBER
PRIMARY	Proportion of Heavy Drinking Days	8 weeks		proportion of heavy drinking days	MEAN
SECONDARY	Measures of Cocaine Craving	8 weeks	subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.	score on a scale	MEAN
SECONDARY	Disease Severity and Improvement	8 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cocaine Withdrawal Severity	8 weeks	subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With a Reduction in Cocaine Use	Vigabatrin	0		participants
Number of Participants With a Reduction in Cocaine Use	Placebo	2		participants
Proportion of Heavy Drinking Days	Vigabatrin	.26	Standard Deviation .18	proportion of heavy drinking days
Proportion of Heavy Drinking Days	Placebo	.20	Standard Deviation .25	proportion of heavy drinking days
Measures of Cocaine Craving	Vigabatrin	1.44	Standard Deviation 2.3	score on a scale
Measures of Cocaine Craving	Placebo	0.38	Standard Deviation 1.1	score on a scale
Disease Severity and Improvement	Vigabatrin	5		Participants
Disease Severity and Improvement	Placebo	2		Participants
Cocaine Withdrawal Severity	Vigabatrin	8.0	Standard Deviation 8.1	score on a scale
Cocaine Withdrawal Severity	Placebo	6.5	Standard Deviation 6.8	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vigabatrin	16
Overall Study	STARTED	Placebo	16
Overall Study	COMPLETED	Vigabatrin	9
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Vigabatrin	7
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Vigabatrin	2	16
other	Nausea	Gastrointestinal disorders	Placebo	0	16
other	Headache	General disorders	Vigabatrin	2	16
other	Headache	General disorders	Placebo	0	16
other	Dry Mouth	General disorders	Vigabatrin	2	16
other	Dry Mouth	General disorders	Placebo	0	16
other	Back Pain	Musculoskeletal and connective tissue disorders	Vigabatrin	2	16
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	0	16
other	URI Symptoms	Respiratory, thoracic and mediastinal disorders	Vigabatrin	2	16
other	URI Symptoms	Respiratory, thoracic and mediastinal disorders	Placebo	3	16

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vigabatrin
Total, all-cause mortality	Placebo
Total, other adverse events	Vigabatrin	10	16
Total, other adverse events	Placebo	13	16
Total, serious adverse events	Vigabatrin	0	16
Total, serious adverse events	Placebo	0	16

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50DA012756	Innovative Approaches for Cocaine Pharmacotherapy	KAMPMAN, KYLE MATTHEW	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE ON DRUG ABUSE	1999 to 2013

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vigabatrin vs Placebo: Disease Severity and Improvement	Trial comparisons
Vigabatrin vs Placebo: Number of Participants With a Reduction in Cocaine Use	Trial comparisons
Vigabatrin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01335867

GET https://conductscience.org/api/trials/v1/NCT01335867/registered

API reference For AI assistants