CMND-100 for Alcoholism

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, CMND-100, to determine its safety and effectiveness for people with Alcohol Use Disorder (AUD), including those who frequently binge drink. The main goal is to identify a safe dose and understand how the body processes the drug. A secondary aim is to assess whether CMND-100 can help reduce drinking and cravings. Suitable candidates have struggled with heavy binge drinking or meet the criteria for AUD and wish to reduce or stop drinking. As a Phase 1 trial, this research focuses on understanding how CMND-100 works in people, offering participants the chance to be among the first to receive this new treatment.

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 there any evidence suggesting that CMND-100 is likely to be safe for humans?

Research has shown that drugs similar to CMND-100, such as acamprosate, have been safe in studies for treating alcohol use disorder (AUD). This suggests that CMND-100 might also be safe. The main goal of this study is to determine a safe dose and observe how the body processes CMND-100.

Researchers carefully monitor participants for any side effects after taking the drug, allowing for quick response to any issues. As an early phase study, the focus is primarily on safety. Researchers aim to ensure there are no serious side effects before proceeding further. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CMND-100 for alcoholism because it offers a potentially new approach to treatment. Unlike most current treatments for alcoholism, which often involve medications that work by reducing cravings or managing withdrawal symptoms, CMND-100 may have a different mechanism of action that directly targets the underlying neural pathways linked to addictive behaviors. This new angle could lead to more effective and faster-acting relief for individuals struggling with alcohol use disorder. Additionally, the treatment's focus on both single and multiple dosing regimens could offer more personalized and adaptable treatment options compared to existing methods.

What evidence suggests that CMND-100 might be an effective treatment for alcoholism?

Research shows that CMND-100 might help reduce the urge to drink alcohol and the amount consumed. This trial divides participants into different parts to evaluate the safety and effectiveness of CMND-100. In Part A, healthy volunteers receive single ascending doses to determine safety. Part B involves binge drinking/AUD subjects receiving single doses to assess tolerability. Part C includes multiple doses for healthy volunteers, while Part D involves multiple doses for binge drinking/AUD subjects. These studies have shown promise in reducing alcohol use, which is encouraging for people with alcohol use disorder (AUD). The treatment affects brain areas linked to alcohol cravings and drinking. While final results are still being collected, early signs suggest CMND-100 could be a helpful tool for managing AUD. ^{1 2 3 4 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05913752

NCT05913752 | A First in Human Study of CMND-100 ... 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 ...

2. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/cmnd-100/

Alcohol Use Disorder (AUD) - Yale School of Medicine CMND-100 (the investigational product) is an investigational oral gelatin capsule being developed for the treatment of Alcohol Use Disorder (AUD) ...

3. clearmindmedicine.com clearmindmedicine.com/news-release/clearmind-medicine-announces-first-u-s-clinical-site-initiation-for-cmnd-100-clinical-trial-in-patients-with-alcohol-use-disorder

CMND-100 The study will also include preliminary efficacy evaluations, examining the drug's potential to reduce alcohol cravings and consumption.

4. withpower.com withpower.com/trial/phase-2-alcoholism-8-2023-eb857

CMND-100 for Alcoholism · Info for Participants 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 ...

5. firstwordpharma.com firstwordpharma.com/story/5942891

Clearmind Medicine Announces Initiation of First in Human ... The Phase I/IIa trial is designed to assess the safety, tolerability, and pharmacokinetics of CMND-100 in individuals diagnosed with AUD. The ...

6. synapse.patsnap.com synapse.patsnap.com/drug/9deb991430f947ca953ee34f8b3a60f2

CMND-100 - Drug Targets, Indications, Patents ... Alcohol Use Disorder (AUD). Discussions underscored MEAI's unique pharmacological profile, promising safety data, and potential advantages over emerging GLP ...