Phase 3
N=207
Vigabatrin for the Treatment of Cocaine Dependency
Cocaine Addiction · Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01281202 ↗Enrolled (actual)
207
Serious AEs
4.4%
Results posted
Feb 2016
Primary outcome: Primary: Abstinence — 5; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vigabatrin (Drug); Matching Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Catalyst Pharmaceuticals, Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abstinence |
5; 9 | — |
| SECONDARY Number of Participants With Cocaine Use |
95; 96; 91; 95; 88; 93 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01281202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.