Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403117
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2006-11-21
Brief Title:
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Opioid Antagonism Enhances Marijuanas Effects in Heavy Marijuana Smokers
Status:
COMPLETED
Status Verified Date:
2018-02
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 determine if the subjective effects of marijuana will be decreased by low-doses 25 mg of naltrexone and increased by high-doses 50 mg of naltrexone
Detailed Description:
Laboratory animal studies demonstrate that endogenous cannabinoids and opioids are closely inter-related We have completed a series of studies in marijuana smokers showing that a clinically-utilized dose of naltrexone 50 mg enhanced the reinforcing and subjective effects of orally-administered tetrahydrocannabinol THC while a low naltrexone dose 12 mg blunted the effects of THC A better understanding of the effects of a range of naltrexone doses in combination with smoked marijuana has important implications for the following reasons 1 Alcohol- and opioid-dependent patients receive high doses of naltrexone 50-150 mg which may increase the abuse liability of marijuana 2 Low-dose naltrexone blunts THCs intoxicating effects suggesting potential utility as a treatment medication for marijuana dependence This study will determine if naltrexone 0 12 25 50 100 mg administration 45 min prior to marijuana administration 0 327 THC alters marijuanas subjective cognitive or physiological effects Marijuana smokers will spend approximately 5hday for a total of 10 days in the outpatient laboratory Participants will visit the outpatient laboratory 2-3 times per week with a minimum 48-hr interval between sessions to allow for naltrexone clearance These data will provide important information regarding the clinical use of naltrexone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| DA09236 | OTHER_GRANT | National Institute on Drug Abuse NIDA | None |