Vigabatrin Ph 1 Cocaine Interaction Study

Cocaine Addiction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626834
• Other study ID #: OV-1014
• Status: Completed
• Phase: Phase 1
• First received: February 18, 2008
• Last updated: January 11, 2017
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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:

Please contact site for more information.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

Drug:
• Vigabatrin
Dose 1 BID
• Vigabatrin
Dose 2 BID
• Vigabatrin
Dose 3 BID
• Matching placebo
Matching placebo BID

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety/tolerability and AE assessments including HR/BP/ECG/QTc		56 days	Yes
Secondary	VGB/PK during cocaine infusions and effect of VGB on cocaine craving		28 days	Yes