Vigabatrin Ph 1 Cocaine Interaction Study

NCT00626834 | Completed Phase 1 DMC

• 1 other identifier: OV-1014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• safety/tolerability and AE assessments including HR/BP/ECG/QTc

  56 days

Secondary Outcomes (1)

• VGB/PK during cocaine infusions and effect of VGB on cocaine craving

  28 days

Study Arms (4)

Vigabatrin Dose 1

EXPERIMENTAL

Drug: Vigabatrin

Vigabatrin Dose 2

EXPERIMENTAL

Drug: Vigabatrin

Vigabatrin Dose 3

EXPERIMENTAL

Drug: Vigabatrin

Matching placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

Vigabatrin DRUG

Dose 1 BID

Vigabatrin Dose 1

Matching placebo DRUG

Matching placebo BID

Matching placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Please contact site for more information.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive; Mental Disorders; Substance-Related Disorders

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 12, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)