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Sponsors and Collaborators: |
New York University School of Medicine Catalyst Pharmaceutical Partners, Inc |
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Information provided by: | New York University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00527683 |
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 | Intervention | Phase |
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Cocaine Dependence |
Drug: Vigabatrin Drug: Placebo Behavioral: Group therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees |
Enrollment: | 100 |
Study Start Date: | April 2007 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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
Behavioral: Group therapy
Participants attend group sessions once a week
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B: Placebo Comparator
Orange juice and administration identical to Arm A.
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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
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In order to participate in the study, subjects must
Exclusion Criteria:
In order to participate in the study, subjects must not:
Be using vigabatrin or any medication that could interact adversely with vigabatrin administration, based on the longest time interval of A or B below:
Mexico, Mexico, D.F. | |
Clinica Integral de Tratamiento Contra las Adicciones SA de CV | |
Mexico City, Mexico, D.F., Mexico, 11560 |
Principal Investigator: | Jonathan D Brodie, Ph.D., M.D. | New York University School of Medicine |
Study Director: | Emilia Figueroa, M.D. | Clinica Integral de Tratamiento Contra las Adicciones, S.A de C.V. |
Responsible Party: | New York University School of Medicine ( Jonathan D. Brodie, PhD, MD, Professor, Dept. of Psychiatry ) |
Study ID Numbers: | H06-152 |
Study First Received: | September 10, 2007 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00527683 History of Changes |
Health Authority: | United States: Institutional Review Board; Mexico: Federal Commission for Sanitary Risks Protection |
vigabatrin GVG addiction treatment cocaine dependence |
Cocaine-Related Disorders Dopamine Uptake Inhibitors Behavior, Addictive Neurotransmitter Agents Vigabatrin Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Cardiovascular Agents |
Anesthetics, Local Dopamine Mental Disorders Substance-Related Disorders Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Cocaine Anticonvulsants |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Vigabatrin Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Anesthetics Mental Disorders Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Substance-Related Disorders |
Cocaine Cocaine-Related Disorders Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Anesthetics, Local GABA Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |