Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine

NCT00218166 | Completed Phase 2

• 3 other identifiers: DA013567R01-13567-1DPMC
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Cocaine abuse continues to represent a significant public-health concern. Cocaine likely creates its addictive effects by increasing levels of dopamine, a chemical found in the brain. GABA agonists are chemicals that have the opposite effect of cocaine by inhibiting the release of dopamine. The purpose of this study is to determine whether GABA agonists reduce the psychological and physiological reinforcing effects of cocaine.

Conditions

Cocaine-Related Disorders

Keywords

cocaine; tiagabine; baclofen

Outcome Measures

Primary Outcomes (1)

• Progressive-ratio break point

  Measured during each experimental session

Secondary Outcomes (2)

• Subjective effects of cocaine

  Measured during each experimental session

• Physiological measures

  Measured throughout the study

Study Arms (1)

A

NO INTERVENTION

Within subject design

Drug: GABA Agonists

Interventions

GABA Agonists DRUG

GABA drugs administered acutely by mouth

Also known as: Triazolam, tiagabine, baclofen

A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Recent use of cocaine
• Meets DSM-IV diagnostic criteria for psychoactive substance abuse or dependence for cocaine
• Positive drug urine screen for cocaine at time of initial screening interview
• Reports self-administration of at least 1,260 mg of cocaine during the 4 weeks prior to study start date
• Body Mass Index (BMI) of less than 29
• Females must use an effective form of contraception throughout the study

You may not qualify if:

• Meets DSM-IV diagnostic criteria for psychoactive substance dependence for substances other than cocaine or nicotine
• Currently seeking treatment for substance abuse/dependence
• Current or past history of physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease
• History of seizure, head traumas, or central nervous system tumors
• Current or past history of serious psychiatric disorder other than substance abuse or dependence
• Family history of cardiovascular disease or seizure disorders

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536 0086, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

GABA Agonists; Triazolam; Tiagabine; Baclofen

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Craig Rush

  ACT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2001
• Primary Completion: May 1, 2005
• Study Completion: May 1, 2005
• Last Updated: January 11, 2017

Record last verified: 2016-10

Locations

US (1)