COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

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: NCT00527683
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : April 11, 2008
Catalyst Pharmaceuticals, Inc.
Information provided by:
NYU Langone Health

Brief Summary:
The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Vigabatrin Drug: Placebo Behavioral: Group therapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Vigabatrin

Arm Intervention/treatment
Active Comparator: A
Subjects will receive vigabatrin in escalating doses to 3 grams per day over three weeks, continued for 4 weeks and then tapered to zero over the next 2 weeks.
Drug: Vigabatrin
crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks
Other Names:
  • Sabril
  • CPP 109
  • gamma vinyl GABA
  • GVG

Behavioral: Group therapy
Participants attend group sessions once a week

Placebo Comparator: B
Orange juice and administration identical to Arm A.
Drug: Placebo
orange juice is administered twice daily in containers indistinguishable from the treatment arm.

Behavioral: Group therapy
Participants attend group sessions once a week

Primary Outcome Measures :
  1. Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). [ Time Frame: These must be the last three weeks (7,8,9) of the trial. ]

Secondary Outcome Measures :
  1. 3 consecutive weeks of negative urines (one slip allowed) [ Time Frame: Last 3 weeks (7,8,9) of the trial ]
  2. cocaine craving [ Time Frame: Weeks 1, 5,9 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

In order to participate in the study, subjects must

  • Be at least 18 years of age and no older than 55 years of age.
  • Weigh more than 100 pounds.
  • Have a DSM-IV diagnosis of cocaine dependence.
  • Be seeking treatment for cocaine dependence.
  • Have a urine sample positive for qualitative cocaine toxicology at initial screening.
  • Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol.
  • Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and the Principal Investigator.
  • Have normal, or, if necessary, corrected visual acuity, visual fields, and normal fundoscopy findings

Exclusion Criteria:

  • In order to participate in the study, subjects must not:

    • Meet DSM-IV criteria for current dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
    • Have neurological or psychiatric disorders such as: psychosis, bipolar illness, major depression, organic brain disease, dementia, any disorder which would require ongoing treatment or which would make study agent compliance difficult, history of suicide attempts assessed and/or current suicidal ideation/plan.
    • Have serious medical illnesses or other potentially life threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct.
    • Have a history of traumatic head injury.
    • Be mandated by a court to obtain treatment for cocaine dependence.
    • Have been treated for cocaine addiction, or abstained from cocaine use for a significant period, within the 6 months preceding screening.
    • Be unable to complete the study protocol because of probable incarceration or relocation from the clinical area.
    • Have AIDS (although AIDS is an exclusion criterion, a positive antibody titer to HIV is not).
    • Have active syphilis that has not been treated or refuse treatment for syphilis
    • Have a history of neuroleptic malignant syndrome.
    • Have known or suspected hypersensitivity to vigabatrin or any other GABAergic drug.
    • Have received a drug with known potential for toxicity to a major organ system within 30 days prior to study entry (e.g., isoniazid, methotrexate).
    • Have participated in any experimental study within 4 weeks, or participated in any clinical trial utilizing vigabatrin.
    • Be pregnant or lactating.
    • Have any clinically significant abnormal laboratory value.
    • Have had electroconvulsive therapy with the 3 months preceding screening.
    • Have had any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months preceding screening.
    • Have a history of i.v. cocaine (or other psychoactive drug) use within 2 months preceding screening.
    • Have a current or past history of seizure disorder, including alcohol- or stimulant related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
    • Have a visual field defect, or factor predisposing to visual field defects, including glaucoma, severe myopia, retinal disorder, cataracts, diabetes or uncontrolled hypertension.
    • Have my illness, condition, and use of medications, in the opinion of the Principal Investigator and the admitting physician, which would preclude safe or successful completion of the study.
    • Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:

      • A) Five half-lives of other medication or active metabolite(s), whichever is longer;
      • B) Two weeks.
    • Be lactose intolerant.

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): NCT00527683

Layout table for location information
Clinica Integral de Tratamiento Contra las Adicciones SA de CV
Mexico City, Mexico, D.F., Mexico, 11560
Sponsors and Collaborators
NYU Langone Health
Catalyst Pharmaceuticals, Inc.
Layout table for investigator information
Principal Investigator: Jonathan D Brodie, Ph.D., M.D. NYU Langone Health
Study Director: Emilia Figueroa, M.D. Clinica Integral de Tratamiento Contra las Adicciones, S.A de C.V.
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jonathan D. Brodie, PhD, MD, Professor, Dept. of Psychiatry, New York University School of Medicine Identifier: NCT00527683    
Other Study ID Numbers: H06-152
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: April 11, 2008
Last Verified: April 2008
Keywords provided by NYU Langone Health:
cocaine dependence
Additional relevant MeSH terms:
Layout table for MeSH terms
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs