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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00626834 |
Purpose
This is a Phase 2a safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Addiction |
Drug: Vigabatrin Drug: Matching placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study |
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2008 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vigabatrin Dose 1 |
Drug: Vigabatrin
Dose 1 BID
|
| Experimental: Vigabatrin Dose 2 |
Drug: Vigabatrin
Dose 2 BID
|
| Experimental: Vigabatrin Dose 3 |
Drug: Vigabatrin
Dose 3 BID
|
| Placebo Comparator: Matching placebo |
Drug: Matching placebo
Matching placebo BID
|
STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers).
Subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge.
STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge.
SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo.
POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Please contact site for more information.
Contacts and Locations| United States, Texas | |
| University of Texas Health Science Center | |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: | John D. Roache, Ph.D. | University of Texas |
| Principal Investigator: | Nora Chiang, Ph.D. | National Institute on Drug Abuse (NIDA) |
| Principal Investigator: | Ahmed Elkashef, M.D. | National Institute on Drug Abuse (NIDA) |
| Principal Investigator: | Roberta Kahn, M.D. | National Institute on Drug Abuse (NIDA) |
More Information
| Responsible Party: | John Roache, Ph.D., University of Texas |
| ClinicalTrials.gov Identifier: | NCT00626834 History of Changes |
| Other Study ID Numbers: | OV-1014 |
| Study First Received: | February 18, 2008 |
| Last Updated: | November 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
cocaine addiction vigabatrin ovation pharmaceuticals cocaine cocaine related disorders behavior addictive mental disorders |
therapeutic uses physiologic effects of drugs disorder of environmental origin central nervous system stimulants central nervous system agents pharmacological actions substance related disorders |
|
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior Impulsive Behavior Substance-Related Disorders Mental Disorders Central Nervous System Stimulants Central Nervous System Agents Cocaine Vigabatrin Gamma-Aminobutyric Acid Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Vasoconstrictor Agents |
Cardiovascular Agents Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents GABA Agents Enzyme Inhibitors Anticonvulsants |
