Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

April 7, 2008 updated by: NYU Langone Health

Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico, D.F.
      • Mexico City, Mexico, D.F., Mexico, 11560
        • Clinica Integral de Tratamiento Contra las Adicciones SA de CV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
  • GVG
  • CPP 109
  • gamma vinyl GABA
Behavioral: Group therapy
Participants attend group sessions once a week
Placebo Comparator: B
Orange juice and administration identical to Arm A.
Behavioral: Group therapy
Participants attend group sessions once a week
Drug: Placebo
orange juice is administered twice daily in containers indistinguishable from the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
These must be the last three weeks (7,8,9) of the trial.

Secondary Outcome Measures

Outcome Measure
Time Frame
3 consecutive weeks of negative urines (one slip allowed)
Time Frame: Last 3 weeks (7,8,9) of the trial
Last 3 weeks (7,8,9) of the trial
cocaine craving
Time Frame: Weeks 1, 5,9
Weeks 1, 5,9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Catalyst Pharmaceuticals, Inc.

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H06-152

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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