CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 207 enrolled
Drug / intervention
Vigabatrin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01281202
NCT01281202Phase 3Completed
CompareCT.gov

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Catalyst Pharmaceuticals, Inc.·interventional·Posted Jan 21, 2011·Updated May 18, 2016

In Brief

A Phase 3 clinical trial evaluating Vigabatrin and Matching Placebo for Cocaine Addiction and Cocaine Dependence. Completed, enrolled 207 participants across 13 sites.

Detailed Summary

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Addiction, Cocaine Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA), VA Office of Research and Development

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 21, 2011
Enrollment StartJan 1, 2011
Primary CompletionOct 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.4 years ago

Interventions

Vigabatrindrug

Tablets

Matching Placebodrug

Tablets