Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence
Information source: Catalyst Pharmaceutical Partners, Inc
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methamphetamine Dependence
Intervention: CPP-109 vigabatrin (Drug); Matching Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Catalyst Pharmaceutical Partners, Inc Official(s) and/or principal investigator(s):
Charles W Gorodetzky, MD, PhD, Study Director, Affiliation: Catalyst Pharmaceutical Partners, Inc
Overall contact:
Douglas Winship, Phone: (305) 529-2522, Ext: 12, Email: dwinship@catalystpharma.com
Summary
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated
subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of
the study's Treatment Phase (Weeks 11 and 12).
Clinical Details
Official title: Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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).
Secondary outcome: • Number of methamphetamine negative urines during the Treatment Phase
• Number of methamphetamine use weeks during the Treatment Phase.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Douglas Winship, Phone: (305) 529-2522, Ext: 12, Email: dwinship@catalystpharma.com
North County Clinical Research (NCCR), Oceanside, California, United States; Recruiting
Angela Hunt, Phone: 760-639-4378
Addiction Pharmacology Research Laboratory, St. Luke's Hospital, San Francisco, California, United States; Recruiting
Kathleen Garrison, Phone: 415-641-3370
South Bay Treatment Center, San Diego, California, United States; Recruiting
Andrea Jaks, Phone: 800-495-0001
Phone: (619) 395-0711
Segal Institute for Clinical Research, N. Miami, Florida, United States; Recruiting
Gustavo Rodriguez, Phone: 877-734-2588
Center on Drug and Alcohol Research, University of Kentucky, Lexington, Kentucky, United States; Recruiting
Lisa Middleton, PhD, Phone: 859-323-3106
Phone: 866-933-4859
Lake Charles Clinical Trials, Lake Charles, Louisiana, United States; Recruiting
Danette Beard, Phone: 337-494-3266
Colleen Smith, Phone: 337-494-3266
START Research and Treatment, Kansas City, Missouri, United States; Recruiting
Carolyn Rowe, Phone: 816-444-5455
Valerie Brown-Davis, Phone: (816) 444-5455
Creighton University Medical Center, Omaha, Nebraska, United States; Recruiting
Wendy Taylor, Phone: 402-345-8828, Ext: 20
Jodette Rose, Phone: 402-345-8828, Ext: 20
Behavioral Health Research Center of the Southwest, Albuquerque, New Mexico, United States; Recruiting
Valerie Wada, Phone: 505-244-3099
Patricia Hokanson, Phone: (505) 244-3099
Pahl Pharmaceutical Research, Oklahoma City, Oklahoma, United States; Recruiting
Gail Carpenter, Phone: 405-525-2222
Ursula Pahl, Phone: 405-525-2222
Pillar Research, Dallas, Texas, United States; Recruiting
Brian Craig, Phone: 214-341-1953
Courtney Stewart, Phone: (214) 341-1953
Additional Information
Starting date: July 2008
Ending date: December 2009
Last updated: November 14, 2008
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