Vigabatrin for Cocaine and Alcohol Dependence

Last updated: September 3, 2019
Sponsor: University of Pennsylvania
Overall Status: Terminated

Phase

2

Condition

Addictions

Alcohol Dependence

Alcohol Use Disorder

Treatment

N/A

Clinical Study ID

NCT01335867
812864
P50DA012756
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and females, 18 years of age or older.

  2. Meets DSM-IV criteria for current diagnoses of cocaine and alcohol dependence,determined by the SCID-IV.

  3. Used cocaine in the past 30 days and used no less than $200 of cocaine in aconsecutive 30 day period over the 90 day period prior to intake. Meets the followingdrinking criteria as measured by the Timeline Followback (TLFB) (Sobell 1995) a drankwithin 30 days of intake day, b. reports a minimum of 48 standard alcoholic (avg. 12drinks/wk) in a consecutive 30-day period over the 90-day period prior to startingintake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavydrinking (defined as greater than 4 drinks per day in males and greater than 3 drinksper day in females) in this same pre-treatment period.

  4. Three consecutive days of abstinence from alcohol directly prior to the day ofrandomization, determined by self-reports and confirmed by negative breathalyzertests, and a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan andSellers 1989) score below eight. Subjects will be given 2 additional weeks beyond thescreening week to attain the appropriate period of alcohol abstinence prior torandomization.

  5. Have a verifiable address of principal residence, lives a commutable distance from theTRC and agrees to attend all research visits including follow-up visits.

  6. Speaks, understands, and prints in English

  7. Ability to give informed consent

Exclusion

Exclusion Criteria:

  1. 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 anypsychoactive medications including any anti-seizure medications (with the exception ofdiphenhydramine used sparingly, if necessary, for sleep).

  2. Meets current or lifetime DSM-IV criteria for schizophrenia or any psychotic disorderor organic mental disorder. Subject meets current DSM-IV diagnosis of any otherclinically significant psychiatric disorder that will interfere with studyparticipation as determined by the principal investigator.

  3. Has evidence of a history of significant hematological, pulmonary, endocrine,cardiovascular, renal or gastrointestinal disease.

  4. Severe physical or medical illnesses such as AIDS, active hepatitis, significanthepatocellular injury as evidenced by elevated total bilirubin levels (>1.3 mg/dl), orelevated levels (over 4.5x normal) of aspartate aminotransferase (AST), and/or alanineaminotransferase (ALT). Patients with Gilberts Syndrome will not be excluded.

  5. Use of an investigational medication in the 30 days prior to randomization.

  6. History of prior treatment with vigabatrin

  7. History of prior treatment with drugs with known retinotoxicity

  8. History of visual field defects or predisposing factors, including glaucoma, severemyopia, retinal disorders, cataracts, diabetes, or uncontrolled hypertension.

  9. Is female and tests positive on a pregnancy test, is contemplating pregnancy in thenext 6 months, is nursing, or is not using an effective contraceptive method (ifrelevant). Acceptable methods of contraception include barrier methods (diaphragm orcondom with spermicide, female condom), intrauterine progesterone contraceptivesystem, levonorgrestrel implant, and medroxyprogesterone acetate contraceptiveinjection, copper IUD, vaginal contraceptive film, cervical cap, contraceptive foam,hormonal vaginal contraceptive ring (NuvaRing®) or oral contraceptives.

Study Design

Total Participants: 32
Study Start date:
April 01, 2011
Estimated Completion Date:
December 31, 2013

Study Description

The hypotheses in the proposed study will be tested with a 2-group design to assess the efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management (MM) manual in weekly dispensing medications, safety checks and medication adherence. The psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.

Study medication will be initiated in Week 2. The research physician will explain the dosing regimen and subjects will be randomly assigned to receive either vigabatrin or identical placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53, and to 1 gram on days 54-56

Connect with a study center

  • University of Pennsylvania, Treatment Research Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

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