Vigabatrin Ph 1 Cocaine Interaction Study
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/13/2017 |
| Start Date: | February 2008 |
| End Date: | October 2010 |
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study
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.
interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent
with intravenous (IV) cocaine infusions.
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.
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.
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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