Cocaine-Related Disorders Clinical Trial
Official title:
The Effects of GABA Medications on Cocaine Responses in Humans
Verified date | July 2015 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 72 |
Est. completion date | September 2006 |
Est. primary completion date | September 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Connecticut Healthcare System | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analog rating scale for drug effects; measured during each experimental session | one week | No | |
Primary | Physiological response to cocaine; measured during each experimental session | one week | No |
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