Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373295
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2006-09-07
Brief Title:
Effect of Baclofen on Marijuana Withdrawal and Relapse
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effect of Baclofen on Marijuana Withdrawal and Relapse
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study is to determine if baclofen dose-dependently decreases marijuanas direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse
Detailed Description:
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use are able to achieve sustained abstinence The objective of this study is to investigate the interaction between marijuana and the potential treatment medication baclofen with the direct goal of using this information to improve marijuana treatment outcome GABAB agonists such as baclofen have been shown to attenuate the self-administration of cocaine heroin alcohol and nicotine see Cousins et al 2002 Haney et al 2006 Baclofen also appears to decrease withdrawal symptoms in heroin and alcohol abusers Akhondzadeh et al 2000 Addolorato et al 2000 The purpose of this study is to determine if baclofen dose-dependently decreases marijuanas direct effects and symptoms of marijuana withdrawal and thus decreases marijuana relapse in our laboratory model For the purposes of this model relapse is defined as a return to marijuana use after a period of abstinence The study will utilize an inpatientoutpatient counter-balanced design with each participant maintained on each of three medication conditions for 16 days placebo and baclofen 60 90 mgday Participants will begin taking capsules during the outpatient phase so that the dose can be incremented up to the maintenance dose prior to the first inpatient day Further clinical studies have shown that baclofen is most effective at decreasing cocaines effects when administered for several weeks During the inpatient study phases participants will have the opportunity to self-administer placebo or active marijuana 6 times per day This study will provide important information of the effect of baclofen as a potential treatment medication for marijuana dependence
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 |
|---|---|---|---|
| 5P50DA009236 | NIH | None | httpsreporternihgovquickSearch5P50DA009236 |