Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218166
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2005-09-16
Brief Title:
Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
GABA Agonists as Pharmacotherapies for Cocaine Abuse
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Cocaine likely creates its reinforcing and addictive effects by increasing levels of dopamine a brain neurotransmitter GABA agonists are chemicals that have the opposite effect by inhibiting the release of dopamine Increasing GABA activity may result in greater inhibition of dopamine systems which may lead to new treatments for cocaine abuse The purpose of this study is to determine whether pretreatment with GABA agonists reduces the psychological and physiological reinforcing effects of cocaine Specifically the study will look at three different GABA agonists tiagabine baclofen and trazolam
This double-blind placebo-controlled study will involve three separate experimental phases each phase will last 4 weeks and will test one of three GABA agonists tiagabine baclofen or trazolam Daily testing sessions will last approximately 6 hours One of four GABA agonist dose treatments will be administered Participants will then be introduced to a sample dose of intranasal cocaine This will allow the participants to become acquainted with the drug effects of the corresponding cocaine dose for that day 0444 5 10 or 20 mg Subjective physiological and performance measures will be obtained This will be followed by a period of cocaine self-administration Participants will be given the opportunity to work on a computer to obtain additional single unit doses of cocaine A total of 8 unit doses of cocaine will be available during each daily session At the end of the daily session additional subjective measures will be evaluated with questionnaires Overall a total of 16 GABA agonist-cocaine dose combinations will be administered on 16 different days A subgroup of participants will also undergo similar procedures with the option to acquire money instead of cocaine At the end of the study all participants will be offered a referral to an appropriate drug-abuse treatment program
This double-blind placebo-controlled study will involve three separate experimental phases each phase will last 4 weeks and will test one of three GABA agonists tiagabine baclofen or trazolam Daily testing sessions will last approximately 6 hours One of four GABA agonist dose treatments will be administered Participants will then be introduced to a sample dose of intranasal cocaine This will allow the participants to become acquainted with the drug effects of the corresponding cocaine dose for that day 0444 5 10 or 20 mg Subjective physiological and performance measures will be obtained This will be followed by a period of cocaine self-administration Participants will be given the opportunity to work on a computer to obtain additional single unit doses of cocaine A total of 8 unit doses of cocaine will be available during each daily session At the end of the daily session additional subjective measures will be evaluated with questionnaires Overall a total of 16 GABA agonist-cocaine dose combinations will be administered on 16 different days A subgroup of participants will also undergo similar procedures with the option to acquire money instead of cocaine At the end of the study all participants will be offered a referral to an appropriate drug-abuse treatment program
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 | None | None | None |
| R01-13567-1 | None | None | None |