Vigabatrin for Cocaine and Alcohol Dependence (VGB)

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01335867
First received: April 13, 2011
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Alcoholism
Cocaine Dependence
Drug: Vigabatrin
Drug: Placebo
Phase 2

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: A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Reduction in cocaine use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples.

  • More alcohol abstinent days and fewer heavy drinking days [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.


Secondary Outcome Measures:
  • Measures of cocaine and alcohol craving [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of cocaine and alcohol craving will be measured using the Minnesota Cocaine Craving Scale and the Penn Alcohol Craving Scale

  • Addiction severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of addiction severity will include the Addiction Severity Index (ASI)

  • Disease severity and improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of disease severity and improvement will include the Clinical Global Impression Scale

  • Alcohol and cocaine withdrawal severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of alcohol and cocaine withdrawal severity will include Clinical Institutes Withdrawal Scale for Alcohol and Cocaine Selective Severity Assessment

  • Depression and anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measures of depression and anxiety will be assessed using the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale


Enrollment: 32
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vigabatrin Drug: Vigabatrin
Vigabatrin escalated to 3 grams daily for 8 weeks
Other Name: Sabril
Placebo Comparator: Placebo Drug: Placebo
Placebo pills

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335867

Locations
United States, Pennsylvania
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Kyle Kampman
Investigators
Principal Investigator: Kyle M Kampman, M.D. University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Kyle Kampman, Sponsor-Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01335867     History of Changes
Other Study ID Numbers: 812864
Study First Received: April 13, 2011
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alcoholism
Cocaine-Related Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Vigabatrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014