Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence - Full Text View

Sponsor:	Catalyst Pharmaceutical Partners, Inc
Information provided by:	Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:	NCT00730522

Purpose

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).

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: CPP-109 vigabatrin Drug: Matching Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Vigabatrin Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by Catalyst Pharmaceutical Partners, Inc:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Number of methamphetamine negative urines during the Treatment Phase • Number of methamphetamine use weeks during the Treatment Phase. [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]

Enrollment:	57
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 CPP-109 vigabatrin tablets	Drug: CPP-109 vigabatrin tablets, bid for 12 weeks Other Names: GVG gamma-vinyl GABA
Placebo Comparator: 2 Matching Placebo Tablets	Drug: Matching Placebo tablets, bid, 12 weeks

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730522

Locations

United States, California
North County Clinical Research (NCCR)
Oceanside, California, United States
South Bay Treatment Center
San Diego, California, United States
Addiction Pharmacology Research Laboratory, St. Luke's Hospital
San Francisco, California, United States
United States, Kentucky
Center on Drug and Alcohol Research, University of Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
United States, Missouri
START Research and Treatment
Kansas City, Missouri, United States
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States
United States, New Mexico
Behavioral Health Research Center of the Southwest
Albuquerque, New Mexico, United States
United States, Oklahoma
Pahl Pharmaceutical Research
Oklahoma City, Oklahoma, United States
United States, Texas
Pillar Research
Dallas, Texas, United States

Sponsors and Collaborators

Catalyst Pharmaceutical Partners, Inc

Investigators

Study Director:

Charles W Gorodetzky, MD, PhD

Catalyst Pharmaceutical Partners, Inc

More Information

No publications provided

Responsible Party:	Douglas Winship-VP of Regulatory Operations, Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:	NCT00730522 History of Changes
Other Study ID Numbers:	CPP-02001
Study First Received:	August 5, 2008
Last Updated:	June 4, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Catalyst Pharmaceutical Partners, Inc:

Methamphetamine
Dependency
Addiction
vigabatrin

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Vigabatrin
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Enzyme Inhibitors
GABA Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012