Evaluating sunobinop for reducing alcohol consumption in people with alcohol use disorder
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Consumption in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
This study is testing if a new medication called sunobinop can help adults with alcohol use disorder drink less compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imbrium Therapeutics Industry-sponsored |
| Locations | 6 sites (Brooklyn, New York and 5 other locations) |
| Trial ID | NCT06545916 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of sunobinop in reducing alcohol consumption compared to a placebo in individuals diagnosed with moderate to severe alcohol use disorder. Participants will be adults aged 18 and older who are actively seeking treatment and have a history of heavy drinking. The study will involve administering either sunobinop or a placebo over a specified period to measure changes in alcohol consumption patterns. The primary focus is to determine if sunobinop can significantly decrease the number of heavy drinking days.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of moderate to severe alcohol use disorder who are seeking treatment.
Not a fit: Patients with current substance use disorders involving substances other than alcohol and nicotine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals struggling with alcohol use disorder.
How similar studies have performed: Other studies have explored treatments for alcohol use disorder, but the specific approach with sunobinop is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Brooklyn, New York and 5 other locations
- Belmont Medical Office — Brooklyn, New York, United States (Recruiting)
- Inquest Clinical Research — Baytown, Texas, United States (Recruiting)
- Cebis Usa, Llc — Houston, Texas, United States (Recruiting)
- Bio Terra Med SRL — Bucharest, Romania (Recruiting)
- Spitalul Universitar De Urgenta Militar Central "Dr. Carol Davila" — Bucharest, Romania (Recruiting)
- Cabinet Medical Individual Dr. Andreea Popa — Bucharest, Romania (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: Medinfo@imbriumthera.com
- Phone: 1-888-827-0622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.