CMND-100 for Alcoholism

Recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Clearmind Medicine Inc.

Must not be taking: Antipsychotics, Antidepressants, MAOIs, others

Disqualifiers: HIV, Seizures, Bipolar, Schizophrenia, others

Compensation: Varies

Number of Visits: 22

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as antipsychotics, mood stabilizers, and some antidepressants, at least 2 weeks before the study and during the study. However, if you are on a stable dose of psychotropic medications, you may continue them if you have been on them for at least 1 month before the study.

Is CMND-100 safe for humans?

There is no specific safety data available for CMND-100, but related compounds like acamprosate have been shown to be safe in clinical trials for alcohol dependence. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-60 with a BMI of 18-35 kg/m2, who are healthy or have Binge Drinking/Alcohol Use Disorder (AUD), and can consent to study procedures. Participants must not be pregnant, breastfeeding, or planning pregnancy soon. They should have normal vital signs and no significant health conditions that could affect the trial.

Inclusion Criteria

All Subjects

Signed informed consent prior to any study-related procedures

Normal vital signs (temperature, heart rate and blood pressure) at screening (heart rate in the range of 50-90, diastolic blood pressure of 50-85 and systolic blood pressure of 90-145)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part A - Single Dose in Healthy Volunteers

Healthy volunteers receive single ascending doses of CMND-100 to evaluate tolerability, safety, and PK/PD.

1 week per cohort

Daily monitoring for 1 week

Part B - Single Dose in AUD Subjects

Subjects with binge drinking/AUD receive single ascending doses of CMND-100 based on Part A results.

1 week per cohort

Daily monitoring for 1 week

Part C - Multiple Dose in Healthy Volunteers

Healthy volunteers receive repeated doses of CMND-100 or placebo for 10 days to evaluate safety, PK/PD, and preliminary efficacy.

10 days

Daily monitoring for 10 days and 1 week post-dosing

Part D - Multiple Dose in AUD Subjects

Subjects with binge drinking/AUD receive repeated doses of CMND-100 or placebo for 10 days based on Part C results.

10 days

Daily monitoring for 10 days and 1 week post-dosing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CMND-100

Trial Overview The study aims to determine the safe dosage of CMND-100 and assess its safety and effects on the body in both healthy volunteers and those with AUD. It will also look at whether CMND-100 can reduce drinking patterns and cravings in subjects with binge drinking or severe AUD.

How Is the Trial Designed?

Group I: Healthy Subjects - Part A Experimental Treatment 1 Intervention

Part A: Single dose (\~ 24 ) Healthy Volunteers: At least four consecutive ascending dose cohorts (20 mg, 40, 80 and 160 mg) will be included in this part of the study in accordance with a pre-defined dose escalating scheme. In each cohort, 6 HVs will receive a single dose of investigation medicine product (CMND-100) starting with the lowest dose of 20 mg. Once dosed, the subjects will be sampled for PK for 24 hours following dosing and will be monitored for drug effects with a physical examination at the end of 24 hours after dosing and daily monitored for safety for a period of 1 week following dosing. Assuming no serious adverse reactions or limiting toxicity (grade 2 and higher) in up to 2, subjects are observed in this dose level, then the next 6 subjects are treated with the next escalated dose, in accordance with a pre-defined dose escalating scheme. The DSMB will review results and guide doses to be studied in Parts B, C and D.

Group II: AUD Subjects - Part D Experimental Treatment 1 Intervention

Multiple dose (18) subjects with binge drinking/AUD: Once Part B and Part C has been completed, the data analyzed and approved by the DSMB, Part D will be initiated. This part will consist of a repeated-dose cohort, based on the higher tolerable dose found in Part C and considering the dose effects found in Part B. Subjects will be randomized into either the treatment or the placebo arm at a ratio of 2:1 (12 subjects treated with the investigation product and 6 subjects receiving placebo) and will receive the drug/placebo at a daily basis for a total of 10 consecutive days. Each subject will be sampled for PK for 24 hours after first and last dosing and will be daily monitored for drug effects and safety throughout the study period and until 1 week after the last dosing. The PK and safety information gathered from in this part of the study will be evaluated by the DSMB.

Group III: AUD Subjects - Part B Experimental Treatment 1 Intervention

Single dose (\~12): After DSMB review of part A, binge drinking/AUD subjects will be enrolled in at least 2 consecutive ascending single dose cohorts using the highest tolerable doses from Part A. The first cohort (n=6) will start with the lower ascending dose and sampled for PK for 24 hours following dosing and will be monitored for drug effects with a physical examination at the end of 24 hours after dosing and daily monitored for safety for a period of 1 week following dosing. Assuming no serious adverse reactions or limiting toxicity are observed in this dose level, then the next 6 subjects are treated with the next escalated dose. At the end of this part, real time PK data from the dose cohorts will be collected and analyzed. PK and safety information from this part of the study and from Part A will be reviewed by the DSMB and will guide the dose to be studied in Part D.

Group IV: AUD Subjects - Part C Placebo Group 1 Intervention

Multiple dose (18) HVs: Once Part A has been completed, the data analysed and approved by the DSMB, Part C will be initiated. This part will consist of a repeated-dose cohort based on the higher tolerable dose found in Part A. HVs will be randomized into either the treatment or the placebo arm at a ratio of 2:1 (12 subjects treated with the investigation product and 6 subjects receiving placebo) and will receive the drug/placebo at a daily basis for a total of 10 consecutive days. Each subject will be sampled for PK for 24 hours after first and last dosing and will be daily monitored for drug effects and safety throughout the study period and until 1 week after the last dosing. Real time PK data will be collected and results analysed (as defined in Section 5.2). The PK and safety information gathered from in this part of the study will be evaluated by the DSMB and will guide the dose to be studied in Part D of this study.

Who Is Running the Clinical Trial?

Clearmind Medicine Inc.

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

Insomnia associated with alcohol cessation (IAAC) is a significant issue for individuals with alcohol use disorder (AUD), often persisting for weeks to years after stopping alcohol use, highlighting a critical unmet need for effective treatments.

A review of 18 studies, including 15 randomized controlled trials, found that while various classes of medications (like antidepressants and anticonvulsants) have been tested for treating sleep disturbances in abstinent AUD patients, none are currently FDA-approved for IAAC, indicating a need for further research on their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery. Roehrs, TA., Auciello, J., Tseng, J., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Sleep disturbance in alcoholism: proposal of a simple measurement, and results from a 24-week randomized controlled study of alcohol-dependent patients assessing acamprosate efficacy. [2018]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Polyamine modulation of NMDARs as a mechanism to reduce effects of alcohol dependence. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Acamprosate in the treatment of alcohol dependence: clinical and economic considerations. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Current and potential pharmacological treatment options for insomnia in patients with alcohol use disorder in recovery. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. [2022]