Vigabatrin for Cocaine and Alcohol Dependence (VGB)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
First received: April 13, 2011
Last updated: October 15, 2013
Last verified: October 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence
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
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Vigabatrin escalated to 3 grams daily for 8 weeks
Other Name: Sabril
Placebo Comparator: Placebo
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335867
|University of Pennsylvania, Treatment Research Center
|Philadelphia, Pennsylvania, United States, 19104 |
||Kyle M Kampman, M.D.
||University of Pennsylvania
No publications provided
||Kyle Kampman, Sponsor-Investigator, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2011
||October 15, 2013
||United States: Food and Drug Administration
United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Agents