Actively Recruiting
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
Led by Clearmind Medicine Inc. · Updated on 2026-03-31
84
Participants Needed
4
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with Alcohol Use Disorder (AUD). The secondary objective of this study is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in subjects with moderate to severe AUD.
CONDITIONS
Official Title
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before study procedures
- Understand and agree to follow all study activities
- Age between 18 and 60 years
- Body mass index between 18 and 35 kg/m2 and weight over 60 kg
- No significant medical conditions or medications that could affect safety or study results
- Male subjects willing to use condoms during and after the study
- Female subjects not pregnant, not breastfeeding, and using adequate contraception if of childbearing potential
- For AUD subjects: diagnosed with AUD by DSM-5 criteria
- AUD subjects must have had at least 4 binge drinking days in the past month
- AUD subjects motivated to reduce or stop drinking
- AUD subjects have stable housing for 3 months before and after screening
- AUD subjects agree to avoid new psychotropic medications except allowed benzodiazepines or stable doses before enrollment
You will not qualify if you...
- Significant medical history or disorders that could interfere with safety or results
- Substance use disorders at screening except alcohol use for AUD subjects and nicotine
- Use of cannabis, other drugs, or nicotine within 5 half-lives before screening
- Signs of alcohol withdrawal or intoxication at screening
- History of seizures or epilepsy
- Major depressive disorder within 1 year, bipolar disorder, schizophrenia, or recent suicidal ideation or attempts
- Uncontrolled illnesses such as active infections
- Abnormal vital signs including high blood pressure or heart rate
- Abnormal ECG readings including QTc > 450 msec
- Significant abnormal liver function, blood counts, or lab abnormalities
- Use of medications that may interact with study drug or experimental drugs/devices recently
- Blood or plasma donation within 90 or 30 days before dosing
- Unable to meet study requirements as judged by investigator
- Healthy subjects unable to abstain from alcohol 72 hours before dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
3
Hadassah Medical Center
Jerusalem, Israel, 91120
Actively Recruiting
4
Tel-Aviv Sourasky Medical Center (TASMC)
Tel Aviv, Israel, 6423906
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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