Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648655
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study to Investigate the Safety and Efficacy of TMP-301 Compared to Placebo in Adult Patients With Alcohol Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Investigator and Participant Blinded Placebo-controlled Parallel-group Study to Investigate the Safety Tolerability and Preliminary Efficacy of TMP-301 Treatment in Adult Patients With Alcohol Use Disorder AUD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious in alcohol use disorder This study is being conducted to evaluate the safety tolerability and efficacy of TMP-301 in patients with alcohol use disorder
Detailed Description:
The purpose of this study is to assess the safety tolerability and effect on alcohol use number of heavy drinking days of TMP-301 compared to placebo in patients with alcohol use disorder This is a placebo-controlled parallel-group multicenter clinical study in moderate to severe alcohol use disorder with 8 heavy drinking days over the prior 4 weeks at screening Study participants and investigators will be blinded to study intervention The study duration will be up to 19 weeks with a treatment duration of up to 14 weeks The visit frequency will be weekly
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