Clinical trial NCT00626834: Vigabatrin Ph 1 Cocaine Interaction Study
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Addiction
Keywords: 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
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2008-02-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1 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.

Detailed description: 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 criteria: Inclusion Criteria:

* Be between 18 and 45 years of age, inclusive
* Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine
* Able to provide written informed consent
* A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine

Exclusion Criteria:

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Primary outcomes:
measure: safety/tolerability and AE assessments including HR/BP/ECG/QTc
timeFrame: 56 days
Secondary outcomes:
measure: VGB/PK during cocaine infusions and effect of VGB on cocaine craving
timeFrame: 28 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: John D. Roache, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Drug Abuse (NIDA)
name: Nora Chiang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Drug Abuse (NIDA)
name: Ahmed Elkashef, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute on Drug Abuse (NIDA)
name: Roberta Kahn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: