Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00142883
Status:
TERMINATED
Last Update Posted:
2015-07-08
First Post:
2005-09-01
Brief Title:
The Effects of GABA Enhancing Medications on Individuals Addicted to Cocaine - 3
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
The Effects of GABA Medications on Cocaine Responses in Humans
Status:
TERMINATED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has been completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 brains 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | OTHER | NIDA | httpsreporternihgovquickSearchP50DA018197-03 |
| P50DA018197-03 | NIH | None | None |