Evaluating sunobinop for reducing alcohol cravings
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
PHASE2 · Imbrium Therapeutics · NCT06545929
This study is testing if a new medication called sunobinop can help adults with alcohol use disorder reduce their cravings for alcohol while they are in treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imbrium Therapeutics (industry) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06545929 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of sunobinop in reducing cravings for alcohol in individuals diagnosed with moderate to severe alcohol use disorder who are actively seeking treatment. Participants will be randomly assigned to receive either sunobinop or a placebo, with the primary focus on measuring changes in alcohol craving levels. The study will include adults aged 18 and older who have experienced significant heavy drinking days in the month prior to enrollment. The goal is to determine if sunobinop can provide a beneficial impact on craving reduction compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates 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 other than alcohol and nicotine may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly help individuals struggling with alcohol cravings, leading to improved outcomes in managing alcohol use disorder.
How similar studies have performed: Other studies have explored treatments for alcohol cravings, 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
Columbus, Ohio
- Ohio Clinical Trials — Columbus, Ohio, United States (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.
Conditions: Alcohol Use Disorder, Alcohol craving, Moderate to severe alcohol use disorder