Vigabatrin for Cocaine and Alcohol Dependence

NCT01335867 | Terminated Phase 2 Results DMC

• 2 other identifiers: 812864P50DA012756
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Conditions

Alcoholism; Cocaine Dependence

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Reduction in Cocaine Use

  The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.

  last 3 weeks of the trial

• Proportion of Heavy Drinking Days

  The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.

  8 weeks

Secondary Outcomes (3)

• Measures of Cocaine Craving

  8 weeks

• Disease Severity and Improvement

  8 weeks

• Cocaine Withdrawal Severity

  8 weeks

Study Arms (2)

Vigabatrin

EXPERIMENTAL

Vigabatrin titrated to 3 grams daily for 8 weeks

Drug: Vigabatrin

Placebo

PLACEBO COMPARATOR

Identical placebo daily for three weeks

Drug: Placebo

Interventions

Vigabatrin DRUG

Vigabatrin escalated to 3 grams daily for 8 weeks

Also known as: Sabril

Vigabatrin

Placebo DRUG

Placebo pills

Also known as: placebo vigabatrin

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and females, 18 years of age or older.
• Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID-IV.
• Used cocaine in the past 30 days and used no less than $200 of cocaine in a consecutive 30 day period over the 90 day period prior to intake. Meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell 1995) a drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as greater than 4 drinks per day in males and greater than 3 drinks per day in females) in this same pre-treatment period.
• Three consecutive days of abstinence from alcohol directly prior to the day of randomization, determined by self-reports and confirmed by negative breathalyzer tests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan and Sellers 1989) score below eight. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of alcohol abstinence prior to randomization.
• Have a verifiable address of principal residence, lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
• Speaks, understands, and prints in English
• Ability to give informed consent

You may not qualify if:

• Meets DSM IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID. Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
• Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation as determined by the principal investigator.
• Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
• Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated total bilirubin levels (\>1.3 mg/dl), or elevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT). Patients with Gilberts Syndrome will not be excluded.
• Use of an investigational medication in the 30 days prior to randomization.
• History of prior treatment with vigabatrin
• History of prior treatment with drugs with known retinotoxicity
• History of visual field defects or predisposing factors, including glaucoma, severe myopia, retinal disorders, cataracts, diabetes, or uncontrolled hypertension.
• Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, female condom), intrauterine progesterone contraceptive system, levonorgrestrel implant, and medroxyprogesterone acetate contraceptive injection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam, hormonal vaginal contraceptive ring (NuvaRing®) or oral contraceptives.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• University of Pennsylvania Center for Studies of Addictions

MeSH Terms

Conditions

Alcoholism; Cocaine-Related Disorders

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kyle M. Kampman, M.D.
• Organization: University of Pennsylvania Treatment Research Center

kampman@pennmedicine.upenn.edu

215 746 2764

Study Officials

• Kyle M Kampman, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

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: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 6, 2019
• Results First Posted: June 12, 2015

Record last verified: 2019-09

Locations

US (1)