Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

NCT00527683 | Completed Phase 2 DMC

• 1 other identifier: H06-152
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

vigabatrin; GVG; addiction; treatment; cocaine dependence

Outcome Measures

Primary Outcomes (1)

• Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed).

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

Secondary Outcomes (2)

• 3 consecutive weeks of negative urines (one slip allowed)

  Last 3 weeks (7,8,9) of the trial

• cocaine craving

  Weeks 1, 5,9

Study Arms (2)

A

ACTIVE COMPARATOR

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; Behavioral: Group therapy

B

PLACEBO COMPARATOR

Orange juice and administration identical to Arm A.

Drug: Placebo; Behavioral: Group therapy

Interventions

Vigabatrin DRUG

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

Also known as: Sabril, CPP 109, gamma vinyl GABA, GVG

A

Placebo DRUG

orange juice is administered twice daily in containers indistinguishable from the treatment arm.

B

Group therapy BEHAVIORAL

Participants attend group sessions once a week

A; B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Catalyst Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Clinica Integral de Tratamiento Contra las Adicciones SA de CV

Mexico City, Mexico City, 11560, Mexico

Location

Related Publications (4)

• Fechtner RD, Khouri AS, Figueroa E, Ramirez M, Federico M, Dewey SL, Brodie JD. Short-term treatment of cocaine and/or methamphetamine abuse with vigabatrin: ocular safety pilot results. Arch Ophthalmol. 2006 Sep;124(9):1257-62. doi: 10.1001/archopht.124.9.1257.

  PMID: 16966620 BACKGROUND

• Brodie JD, Figueroa E, Laska EM, Dewey SL. Safety and efficacy of gamma-vinyl GABA (GVG) for the treatment of methamphetamine and/or cocaine addiction. Synapse. 2005 Feb;55(2):122-5. doi: 10.1002/syn.20097.

  PMID: 15543630 BACKGROUND

• Brodie JD, Figueroa E, Dewey SL. Treating cocaine addiction: from preclinical to clinical trial experience with gamma-vinyl GABA. Synapse. 2003 Dec 1;50(3):261-5. doi: 10.1002/syn.10278. No abstract available.

  PMID: 14515344 BACKGROUND

• Brodie JD, Case BG, Figueroa E, Dewey SL, Robinson JA, Wanderling JA, Laska EM. Randomized, double-blind, placebo-controlled trial of vigabatrin for the treatment of cocaine dependence in Mexican parolees. Am J Psychiatry. 2009 Nov;166(11):1269-77. doi: 10.1176/appi.ajp.2009.08121811. Epub 2009 Aug 3.

  PMID: 19651710 DERIVED

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive

Interventions

Vigabatrin; Psychotherapy, Group

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jonathan D Brodie, Ph.D., M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Emilia Figueroa, M.D.

  Clinica Integral de Tratamiento Contra las Adicciones, S.A de C.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 11, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 11, 2008

Record last verified: 2008-04

Locations

ME (1)