Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03386487
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2017-12-21
Brief Title:
Fatty Acid Amide Hydrolase FAAH Inhibitor Treatment of Cannabis Use Disorder CUD
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Phase 2B 8-week Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate Efficacy Safety and Tolerability of the Fatty Acid Amide Hydrolase FAAH Inhibitor PF-04457845 in Adults With DSM5 Current Cannabis Use Disorder CUD
Status:
COMPLETED
Status Verified Date:
2024-02
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:
FAAH-I MULTI
Brief Summary:
A Phase 2B 8-Week Randomized Double-Blind Placebo-Controlled Parallel Group Study to Evaluate the Efficacy Safety and Tolerability of the Fatty Acid Amide Hydrolase FAAH Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder CUD
Detailed Description:
The efficacy safety and tolerability of the FAAH Inhibitor PF-0447845 in reducing cannabis use will be studied in a 4-site randomized double-blind placebo-controlled parallel-group outpatient clinical trial comparing PF-04457845 4mg and placebo in DSM-5 CUD individuals Participants will be randomized in a 11 ratio to either PF-04457845 or placebo using random block sizes of 2 and 4 stratified by site and degree of cannabis use Participants will receive motivational interviewing for 2 weeks before being randomized to receive study medication to make a quit attempt within the first week of treatment Participants will receive active or placebo PF-04457845 for 8 weeks during which time they will be evaluated weekly in face to face visits In addition daily assessment of adherence to study medication and cannabinoid use will be conducted daily by cellphone Measures of cannabinoid exposure self-reported and urine toxicology and problems related to the use of cannabis will be assessed
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 |
|---|---|---|---|
| 1U01DA045372-01 | NIH | None | httpsreporternihgovquickSearch1U01DA045372-01 |