Vigabatrin for the Treatment of Cocaine Dependency

Cocaine Dependence Clinical Trial

Official title:

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01281202
• Other study ID #: CPP-01005/CS# 1030 TRANSFERRED
• Secondary ID: Y1-DA4006
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 20, 2011
• Last updated: May 16, 2016
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: May 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

There are 3 Phases to this study:

• a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested;

• a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and

• a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand the study and provide written informed consent.

• Male or female at least 18 years of age.

• Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module.

• Have a verifiable place of primary residence.

• Seeking treatment for cocaine dependence.

• Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings.

• If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable.

Exclusion Criteria:

• Please contact site for more information

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine Addiction
• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Vigabatrin
Tablets
• Matching Placebo
Tablets

Locations

Country	Name	City	State
United States	Pacific Institute for Research and Evaluation	Albuquerque	New Mexico
United States	Mountain Manor Treatment Center @ Baltimore	Baltimore	Maryland
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Pillar Clinical Research, LLC	Dallas	Texas
United States	VA Medical Center	Denver	Colorado
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Matrix Institute on Addictions	Los Angeles	California
United States	University of Miami School of Medicine	Miami	Florida
United States	NeuroPsychiatric Research & Practice Assoc., Ltd.	Oak Brook	Illinois
United States	Western Psychiatric Inst. and Clinic	Pittsburgh	Pennsylvania
United States	George E Wahlen VA Medical Center	Salt Lake City	Utah
United States	Friends Research Institute	Torrance	California

Sponsors (3)

Lead Sponsor	Collaborator
Catalyst Pharmaceuticals, Inc.	National Institute on Drug Abuse (NIDA), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence	The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).	Weeks 8-9	Yes
Secondary	Number of Participants With Cocaine Use		Week 3 - 9	No