Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence

NCT00730522 | Terminated Phase 2 Results

• 1 other identifier: CPP-02001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Methamphetamine Dependence

Keywords

Methamphetamine; Dependency; Addiction; vigabatrin

Outcome Measures

Primary Outcomes (1)

• 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).

  Weeks 11-12

Secondary Outcomes (1)

• • Number of Methamphetamine Negative Urines During the Treatment Phase • Number of Methamphetamine Use Weeks During the Treatment Phase.

  Weeks 1-12

Study Arms (2)

1

ACTIVE COMPARATOR

CPP-109 vigabatrin tablets

Drug: CPP-109 vigabatrin

2

PLACEBO COMPARATOR

Matching Placebo Tablets

Drug: Matching Placebo

Interventions

CPP-109 vigabatrin DRUG

tablets, bid for 12 weeks

Also known as: GVG, gamma-vinyl GABA

1

Matching Placebo DRUG

tablets, bid, 12 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catalyst Pharmaceuticals, Inc.: lead

Study Sites (8)

North County Clinical Research (NCCR)

Oceanside, California, United States

Location

South Bay Treatment Center

San Diego, California, United States

Location

Addiction Pharmacology Research Laboratory, St. Luke's Hospital

San Francisco, California, United States

Location

START Research and Treatment

Kansas City, Missouri, United States

Location

Creighton University Medical Center

Omaha, Nebraska, United States

Location

Behavioral Health Research Center of the Southwest

Albuquerque, New Mexico, United States

Location

Pahl Pharmaceutical Research

Oklahoma City, Oklahoma, United States

Location

Pillar Research

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study terminated early due to other failed indication for product and only limited data collected without complete analysis. CPP-109 stopped all development in substance dependent indications. Therefore, not able to summarize most data, as not available.

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Catalyst Pharmaceuticals

gingenito@catalystpharma.com

305-420-3200

Study Officials

• Charles W Gorodetzky, MD, PhD

  Catalyst Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-10

Locations

US (8)