Cocaine Dependence Clinical Trial
Official title:
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Catalyst Pharmaceuticals, Inc. | National Institute on Drug Abuse (NIDA), VA Office of Research and Development |
United States,
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 |
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