This study is designed to evaluate the safety and tolerability of CMND-100 in adults with alcohol use disorder (AUD). Researchers will also examine how the body absorbs, processes, and responds to the investigational study drug after a single dose to help determine its potential for future treatment of AUD.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Ages 18-60
• Drink alcohol heavily
• Interested in reducing or stopping alcohol use
• Willing to stay overnight at a clinical research unit
• At least 4 binge-drinking days in the past month

Exclusion Criteria:

• Recent major depressive disorder, bipolar disorder, schizophrenia, suicidal thoughts, or suicide attempts
• Current substance use disorder other than alcohol or nicotine
• History of seizures or epilepsy

If you are interested in participating, you will first complete a 15–20 minute phone prescreen to determine whether you may qualify.

If you appear eligible, you will:

1. Attend an in-person screening visit for health assessments and eligibility testing.
2. Return for your study visit, where you will receive one oral dose of the investigational medication.
3. Stay overnight at the clinical research unit for monitoring, including blood and urine collection, vital sign checks, ECGs, and health assessments.
4. Complete two follow-up phone calls after discharge.
5. Return approximately one week later for a final in-person follow-up visit that includes additional health checks, an ECG, and blood and urine testing.

Participation lasts approximately 8–10 days.

Participants will receive $50 for completing the screening visit and may receive up to a total of $1,425 for completing all study procedures.

Transportation assistance may be available and can include parking passes, bus tokens, or Uber/Lyft transportation, depending on the study visit.

During the overnight stay, participants will receive three meals and snacks and have a private room with a private bathroom and shower. Rooms include a Smart TV with Netflix and other streaming services. Participants also have access to on-site laundry during designated hours and a communal sunroom with games, a PlayStation 5, an exercise bike, books, and puzzles.

There is no cost for you to participate in our research study.