NCT05913752 · Clearmind Medicine Inc.
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
What this study is about
The primary objective of this study is to find the tolerable dose and characterize the safety and how the drug moves through the body/ how the drug affects the body (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with Binge Drinking/Alcohol Use Disorder (AUD).
View original scientific description
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 Binge Drinking/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 binge drinking or/and moderate to severe AUD.
Interventions
DRUG
CMND-100
The investigational product CMND-100 consists of gelatin capsules, each containing the active ingredient (either 20 or 60 mg) 5-methoxy-2-aminoindane (MEAI) and excipients (stabilizers). MEAI is a psychoactive compound of the aminoindane class
Primary outcome measures
Safety as Adverse Events Profile
Time frame: up to 31 days
Incidence of adverse events and classification in terms of severity, causality and outcome
Tmax
Time frame: up to 31 days
Time to maximum plasma concentration
Cmax
Time frame: up to 31 days
Maximum plasma concentration
AUC0-∞
Time frame: up to 31 days
Area under the concentration-time curve from 0 minutes extrapolated to infinity
t1/2
Time frame: up to 31 days
Terminal elimination phase half-life expressed in time units
Cl
Time frame: up to 31 days
The volume of plasma cleared of the drug per unit time
Vd
Time frame: up to 31 days
The volume in which a drug is distributed
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All Subjects
- Signed informed consent prior to any study-related procedures,
- Subjects understand the nature and the procedures related with the study design of the trial and accept to fulfill all activities related to this trial,
- Subjects 18 to 60 years of age,
- Body mass index between 18 and 35 kg/m2,
- No (history of) clinically significant conditions and/or concomitant medications which in the opinion of the investigator could endanger the safety of the subject or impact the validity of the study results,
- Male subjects who wish use condoms for the duration of the study and for a suitable time period after the last drug dose (e.g., 5 half-lives),
- Female subjects who are not pregnant or breast-feeding or who do not wish to become pregnant during the period of the clinical study and for three months later,
- Female subjects of childbearing potential (less than 24 months after the last menstrual cycle) who use adequate contraceptive methods. Adequate cont
Where
- New Haven, Connecticut
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations