Status:
RECRUITING
Study of Sunobinop on Alcohol Consumption in Alcohol Use Disorder
Lead Sponsor:
Imbrium Therapeutics
Collaborating Sponsors:
Purdue Pharma LP
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol consumption in subjects with alcohol use disorder.
Eligibility Criteria
Inclusion
- Key Inclusion Criteria include:
- Male and female age ≥18 years.
- Diagnosis of moderate or severe alcohol use disorder.
- Currently seeking treatment for alcohol use disorder.
- Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.
- Key Exclusion Criteria include:
- Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
- Other protocol-specific inclusion and exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06545916
Start Date
October 14 2024
End Date
March 1 2026
Last Update
September 29 2025
Active Locations (7)
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1
Belmont Medical Office
Brooklyn, New York, United States, 11212
2
Ohio Clinical Trials
Columbus, Ohio, United States, 43212
3
Inquest Clinical Research
Baytown, Texas, United States, 77521
4
Cebis Usa, Llc
Houston, Texas, United States, 77074