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| Sponsored by: |
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: | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Vigabatrin Dose 1: Experimental |
Drug: Vigabatrin
Dose 1 BID
|
| Vigabatrin Dose 2: Experimental |
Drug: Vigabatrin
Dose 2 BID
|
| Vigabatrin Dose 3: Experimental |
Drug: Vigabatrin
Dose 3 BID
|
| Matching placebo: Placebo Comparator |
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| Contact: Jurij Mojsiak | 301-443-9804 | jm200p@nih.gov |
| Contact: Liza Gorgon | 301-443-1138 | lgorgon@nih.gov |
| United States, Texas | |
| University of Texas Health Science Center | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Bill Murff 210-358-1279 murff@uthscsa.edu | |
| Contact: Alex Carrizales 210-358-1211 carrizalesf@uthscsa.edu | |
| Principal Investigator: John D Roache, Ph.D. | |
| 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: | University of Texas ( John Roache, Ph.D. ) |
| Study ID Numbers: | OV-1014 |
| Study First Received: | February 18, 2008 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00626834 History of Changes |
| 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 |
|
Dopamine Uptake Inhibitors Cocaine-Related Disorders Neurotransmitter Agents Behavior, Addictive Vigabatrin Central Nervous System Depressants Anesthetics Disorders of Environmental Origin Central Nervous System Stimulants Cardiovascular Agents |
Anesthetics, Local Dopamine Mental Disorders Gamma-Aminobutyric Acid 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 Central Nervous System Stimulants Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Anesthetics, Local GABA Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |
