Vigabatrin for Cocaine and Alcohol Dependence (VGB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01335867
Recruitment Status : Terminated
First Posted : April 14, 2011
Results First Posted : June 12, 2015
Last Update Posted : December 29, 2016
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Alcoholism Cocaine Dependence Drug: Vigabatrin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence
Study Start Date : April 2011
Primary Completion Date : April 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vigabatrin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vigabatrin Drug: Vigabatrin
Vigabatrin escalated to 3 grams daily for 8 weeks
Other Name: Sabril
Placebo Comparator: Placebo Drug: Placebo
Placebo pills

Primary Outcome Measures :
  1. Number of Participants With a Reduction in Cocaine Use [ Time Frame: 3 weeks ]
    The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples.

  2. More Alcohol Abstinent Days and Fewer Heavy Drinking Days [ Time Frame: 8 weeks ]
    The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.

Secondary Outcome Measures :
  1. Measures of Cocaine and Alcohol Craving [ Time Frame: 8 weeks ]
    Measures of cocaine and alcohol craving will be measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale

  2. Addiction Severity [ Time Frame: 8 weeks ]
    Measures of addiction severity will include the Addiction Severity Index (ASI)

  3. Disease Severity and Improvement [ Time Frame: 8 weeks ]
    Measures of disease severity and improvement will include the Clinical Global Impression Scale

  4. Alcohol and Cocaine Withdrawal Severity [ Time Frame: 8 weeks ]
    Measures of alcohol and cocaine withdrawal severity will include Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment

  5. Depression and Anxiety [ Time Frame: 8 weeks ]
    Measures of depression and anxiety will be assessed using the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  4. 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.
  5. 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.
  6. Speaks, understands, and prints in English
  7. Ability to give informed consent

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 any psychoactive medications including any anti-seizure medications (with the exception of diphenhydramine used sparingly, if necessary, for sleep).
  2. 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.
  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, 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.
  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, severe myopia, retinal disorders, cataracts, diabetes, or uncontrolled hypertension.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01335867

United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kyle M Kampman, M.D. University of Pennsylvania

Additional Information:
Responsible Party: University of Pennsylvania Identifier: NCT01335867     History of Changes
Other Study ID Numbers: 812864
First Posted: April 14, 2011    Key Record Dates
Results First Posted: June 12, 2015
Last Update Posted: December 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Enzyme Inhibitors
GABA Agents