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Vigabatrin for the Treatment of Cocaine Dependency

NCT01281202 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2016-05-18

Study results available
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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.

Conditions

  • Cocaine Addiction
  • Cocaine Dependence

Interventions

DRUG

Vigabatrin

Tablets

DRUG

Matching Placebo

Tablets

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • VA Office of Research and Development

    collaborator FED

  • Catalyst Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Kathleen Brady, MD, PhD · Medical University of South Carolina

  • Christopher J Stock, PharmD · George E. Wahlen VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-10-31
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01281202 on ClinicalTrials.gov