Clinical trial NCT01281202: Vigabatrin for the Treatment of Cocaine Dependency
Official title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cocaine Addiction
Cocaine Dependence
Keywords: Cocaine
Cocaine Addiction Treatment
Cocaine Treatment
Vigabatrin
CPP-109
Catalyst
National Institute on Drug Abuse
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Office of Research and Development
First posted: 2011-01-21
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Abstinence
timeFrame: Weeks 8-9
Secondary outcomes:
measure: Number of Participants With Cocaine Use
timeFrame: Week 3 - 9
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Institute on Addictions
state: California
city: Torrance
country: United States
facility: Friends Research Institute
state: California
city: Denver
country: United States
facility: VA Medical Center
state: Colorado
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Oak Brook
country: United States
facility: NeuroPsychiatric Research & Practice Assoc., Ltd.
state: Illinois
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center @ Baltimore
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Albuquerque
country: United States
facility: Pacific Institute for Research and Evaluation
state: New Mexico
city: Pittsburgh
country: United States
facility: Western Psychiatric Inst. and Clinic
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: George E Wahlen VA Medical Center
state: Utah
Study officials:
affiliation: Medical University of South Carolina
name: Kathleen Brady, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George E. Wahlen VA Medical Center
name: Christopher J Stock, PharmD
role: STUDY_CHAIR
References: