- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00730522
Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks.
At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Oceanside, California, United States
- North County Clinical Research (NCCR)
-
San Diego, California, United States
- South Bay Treatment Center
-
San Francisco, California, United States
- Addiction Pharmacology Research Laboratory, St. Luke's Hospital
-
-
Missouri
-
Kansas City, Missouri, United States
- START Research and Treatment
-
-
Nebraska
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Omaha, Nebraska, United States
- Creighton University Medical Center
-
-
New Mexico
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Albuquerque, New Mexico, United States
- Behavioral Health Research Center of the Southwest
-
-
Oklahoma
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Oklahoma City, Oklahoma, United States
- Pahl Pharmaceutical Research
-
-
Texas
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Dallas, Texas, United States
- Pillar Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Able to understand the study and provide written informed consent.
- Male or female at least 18 years of age.
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for methamphetamine dependence as major diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
- Provides at least one urine specimen which is positive for methamphetamine according to a rapid screening test.
- Seeking treatment for methamphetamine dependence.
- Have normal visual fields.
- Be in generally good health based on history, physical examination and laboratory findings.
- If female of childbearing potential, use acceptable contraceptive methods
Exclusion Criteria:
- Has current dependence on any psychoactive substance other than methamphetamine, alcohol, nicotine, or cannabinoid or physiologic dependence on alcohol requiring medical detoxification.
- Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory values.
- Has history of serious cardiovascular reaction to methamphetamine.
- Has clinically significant cardiovascular impairment, abnormal ECG or uncontrolled hypertension.
- Be under court or other governmental agency (e.g. social services) mandate to obtain treatment or requiring outside urine monitoring.
- Be enrolled in an opiate substitution treatment program within 2 months of randomization.
- Has ever taken vigabatrin in the past.
- Is pregnant or lactating.
- Has clinically significant ophthalmologic disease, which would preclude safety monitoring, is undergoing treatment for ocular disease or intends to have any ocular surgery or procedure performed during the time of their participation in the trial.
- Has received a drug with known major organ toxicity, including retinotoxicity.
- Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
- Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
CPP-109 vigabatrin tablets
|
tablets, bid for 12 weeks
Other Names:
|
PLACEBO_COMPARATOR: 2
Matching Placebo Tablets
|
tablets, bid, 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Proportion of Subjects in Each Treatment Group Who Are Amphetamine Abstinent During the Last 2 Weeks of the Treatment Phase (Weeks 11 and 12).
Time Frame: Weeks 11-12
|
Weeks 11-12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
• Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase.
Time Frame: Weeks 1-12
|
Weeks 1-12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Charles W Gorodetzky, MD, PhD, Catalyst Pharmaceuticals, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPP-02001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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