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Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

NCT00527683 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-04-11

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

Principal Investigators

  • Jonathan D Brodie, Ph.D., M.D. · NYU Langone Health

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00527683 on ClinicalTrials.gov