Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-01 @ 9:11 AM
Study NCT ID:
NCT00218166
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2005-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of GABA Agonists in Reducing the Reinforcing Effects of Cocaine
Sponsor:
National Institute on Drug Abuse (NIDA)
Organization:
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 (0.444, 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 (0.444, 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:
False
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?: