Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT00527683

Collaborator

Catalyst Pharmaceuticals, Inc. (Industry)

100

Enrollment

Location

Arms

Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Apr 1, 2007

Actual Primary Completion Date :

Nov 1, 2007

Actual Study Completion Date :

Nov 1, 2007

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

3 consecutive weeks of negative urines (one slip allowed) [Last 3 weeks (7,8,9) of the trial]
cocaine craving [Weeks 1, 5,9]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.

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.