The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3

NCT00142883 | Terminated DMC

• 3 other identifiers: NIDA-18197-3P50DA018197-03DPMC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Gamma-aminobutyric acid (GABA) is a type of neurotransmitter, which is a chemical that transmits information within and from the brain to all parts of the body. By lowering the level of another neurotransmitter called dopamine, GABA may have the ability to diminish cocaine cravings in addicts. The purpose of this study is to gather information on the interaction between cocaine and selected GABA enhancing medications in individuals addicted to cocaine. This may lead to future clinical studies using GABA medications to treat cocaine addiction.

Conditions

Cocaine Abuse; Cocaine-Related Disorders

Keywords

addiction, crack, cocaine

Outcome Measures

Primary Outcomes (2)

• Analog rating scale for drug effects; measured during each experimental session

  one week

• Physiological response to cocaine; measured during each experimental session

  one week

Study Arms (2)

pregabalin

ACTIVE COMPARATOR

pregabalin compared to placebo

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

Placebo compared to pregabalin

Drug: placebo

Interventions

Pregabalin DRUG

pregabalin compared to placebo

Also known as: lyrica

pregabalin

placebo DRUG

sugar pill compared to pregabalin

Also known as: sugar pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Meets DSM-IV criteria for cocaine dependence
• History of smoked or intravenous cocaine use on average of at least once a week over a 6 month period
• Positive urine test for cocaine
• No current medical problems
• Normal electrocardiogram
• If female, willing to use contraception throughout the study

You may not qualify if:

• Seeking treatment for cocaine dependence
• Current major psychiatric illness, including mood disorder, psychotic disorder, or anxiety disorder
• Current dependence on alcohol or any drugs other than cocaine or nicotine
• History of major medical illness, including liver disease, suspected or known cancer, thrombophlebitis, or other medical conditions that are considered unsafe for study participants by the investigator
• Known allergy to study medications
• Pregnant or breastfeeding

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive

Interventions

Pregabalin; Sugars

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas R Kosten, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: September 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

US (1)