Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00527683
• Date of registration: 10/09/2007
• Primary sponsor: New York University School of Medicine
• Public title: Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence
• Scientific title: Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees
• Date of first enrolment: April 2007
• Target sample size: 100
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00527683
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Mexico

Contacts

• Name: Emilia Figueroa, M.D.
• Affiliation: Clinica Integral de Tratamiento Contra las Adicciones, S.A de C.V.

• Name: Jonathan D Brodie, Ph.D., M.D.
• Affiliation: New York University School of Medicine

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cocaine Dependence

Intervention(s)

Behavioral: Group therapy

Drug: Placebo

Drug: Vigabatrin

Primary Outcome(s)

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(s)

3 consecutive weeks of negative urines (one slip allowed) [Time Frame: Last 3 weeks (7,8,9) of the trial]

cocaine craving [Time Frame: Weeks 1, 5,9]

Secondary ID(s)

H06-152

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Catalyst Pharmaceutical Partners, Inc