The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effects of GABA Medications on Cocaine Responses in Humans|
- Analog rating scale for drug effects; measured during each experimental session [ Time Frame: one week ] [ Designated as safety issue: No ]
- Physiological response to cocaine; measured during each experimental session [ Time Frame: one week ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||September 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Active Comparator: pregabalin
pregabalin compared to placebo
pregabalin compared to placebo
Other Name: lyrica
Placebo Comparator: Placebo
Placebo compared to pregabalin
sugar pill compared to pregabalin
Other Name: sugar pill
GABA is an inhibitory neurotransmitter that is found primarily in the brain. High GABA levels result in low levels of dopamine, another neurotransmitter that is the brain's "feel good" chemical and which plays a primary role in cocaine drug addiction. Cravings for cocaine can be reduced by lowering dopamine levels. This makes GABA-altering medications a potential treatment for cocaine addiction. This study will involve five GABA enhancing medications: tiagabine, topiramate, valproic acid, baclofen, and progesterone. The purpose of the study is to evaluate the interaction between GABA medications and cocaine in terms of safety and craving responses. In turn, these findings may guide future cocaine pharmacotherapy trials.
This 6-day inpatient study will begin with an orientation session to familiarize participants with study procedures. The evening of Day 1, all participants will receive placebo medication. On Days 2 through 4, participants will receive one of five GABA medications. The GABA medications will be given in gradually increasing doses to attain therapeutic levels while maintaining safety and minimizing side effects. Three experimental cocaine sessions will take place; one while the participants are receiving the placebo medication and two while the participants are receiving the GABA medications. During these sessions, cocaine will be administered intravenously in three increasing doses, each separated by 30-minute intervals. This will allow the participants' subjective and physiological responses during cocaine administration to return to baseline levels before the next dose. Blood will be drawn after each dose; heart rate, blood pressure, and an ECG will be monitored throughout the sessions. At the end of each session, questionnaires will be administered to assess the effects of cocaine and related mood states, as well as allow the participants to report any adverse events, depression, craving, or withdrawal symptoms.
This study is now closed and published.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142883
|United States, Connecticut|
|VA Connecticut Healthcare System|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Thomas R Kosten, MD||Yale University|