Vigabatrin for the Treatment of Cocaine Dependency

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cocaine Addiction, Cocaine Dependence

In brief

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.

Key facts

Study ID

NCT01281202

Run by

Catalyst Pharmaceuticals, Inc.

People needed

207

Starts

2011-01-01

Expected to finish

2012-12-01

Last updated by the study team

2016-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Please contact site for more information

Where it is running

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

Full record on ClinicalTrials.gov

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