Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373503
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
2006-09-07
Brief Title:
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Effect of Lofexidine and Oral THC on Marijuana Withdrawal and Relapse
Status:
COMPLETED
Status Verified Date:
2013-02
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 investigate the interaction between marijuana and two potential treatment medications lofexidine and oral THC with the direct goal of using this information to improve marijuana treatment outcome
Detailed Description:
Only a small percentage of dependent-marijuana smokers who are seeking treatment for their marijuana use is able to achieve sustained abstinence The objective of this study is to investigate the interaction between marijuana and two potential treatment medications lofexidine and oral THC with the direct goal of using this information to improve marijuana treatment outcome In mice the α2-receptor agonist clonidine reversed symptoms of cannabinoid withdrawal Lichtman et al 2001 The purpose of this study is to determine if lofexidine an α2-receptor agonist with a more favorable side-effect profile than clonidine decreases symptoms of marijuana withdrawal and thus decreases marijuana relapse as compared to placebo Oral THC is FDA-approved for appetite enhancement Lofexidine which is currently not FDA-approved is used in Europe to treat symptoms of heroin withdrawal and to treat hypertension For the purposes of this model relapse is defined to a return to marijuana use after a period of abstinence We have shown that oral THC reduces symptoms of marijuana withdrawal at doses that produce minimal intoxication Haney et al 2004 Thus the effects of oral THC alone and in combination with lofexidine will be determined The study will utilize an inpatientoutpatient counter-balanced design with each participant maintained on each of four medication conditions for 8 days each placebo lofexidine oral THC and oral THC combined with lofexidine During the inpatient study phases participants will have the opportunity to self-administer placebo or active marijuana 6 times per day Outpatient phases are for medication clearance so no medications will be administered This study will provide important information of the effect of these potential treatment medications on both marijuana withdrawal symptoms and on subsequent marijuana self-administration
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 |
|---|---|---|---|
| R01DA019239 | NIH | None | httpsreporternihgovquickSearchR01DA019239 |