A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with Binge Drinking/ Alcohol Use Disorder (AUD)
- Study IRB#:2000035043
- Last Updated:10/30/2026
The primary objective of this four-part study (Part A, B, C and D) is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose CMND-100 in Healthy Volunteers (HV) and participants 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 participants with binge drinking or/and moderate to severe AUD.
We are currently only recruiting for Part B of this research study. Part B will enroll volunteers with alcohol use disorder only and will use a single ascending dose in this research. Part B of the study should provide the maximum tolerable dose and early pharmacokinetic data. CMND-100 (the investigational product) is an investigational oral gelatin capsule being developed for the treatment of Alcohol Use Disorder (AUD). CMND-100 is a psychoactive compound with similarity to MDMA (ecstasy). We will discuss this part during consent visit.
Alcohol Use Disorder (AUD) is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences. If you are interested in participating in this study and meet the criteria set for Part B, your participation may last approximately 22 days. You will be randomly assigned to either receive CMND-100 or a placebo.
On the dosing day, you will have your blood drawn and vitals taken at multiple time points while under 24-hour inpatient monitoring. The dosing day will be video-recorded.
Participation involves undergoing a phone screening, informed consent, medical evaluation, and completing the study procedures, as listed below: Screening period. This period will last up to 14 days before the start of treatment with CMND-100 or placebo. During this time, your study doctor will assess your medical history and current condition and determine whether you are suitable to participate in the study.
Treatment period: this period will consist of one treatment day in which you will receive CMND-100 and will last up to 24 hours after receiving CMND-100, when safety parameters and blood levels of the drug will be determined.
Safety Follow up: this period will last up to one week after CMND-100 administration, and during this period safety parameters will be examined. You will be requested to present to the Connecticut Mental Health Center three times during the research trial, and for the second visit you will be required to stay at the Connecticut Mental Health Center on the clinical research inpatient unit for approximately 24 hours for close monitoring and frequent blood sample taking to measure blood levels of the product. You will be contacted by phone an additional two times after you are discharged.
Risks Associated with Study Participation: Risks associated with study participation include anxiety, aggressiveness, sensitivity reactions, tremor, salivation, nausea, diarrhea and mild euphoria and/or “tipsy”. These feelings might be addictive and cause you to want more of CMND-100. Total estimated compensation is $625.
https://medicine.yale.edu/lab/abn/trial/cmnd-100/
- Age18 years - 60 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Alec Yariel Luna
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call 877-978-8343 for more information.
Study Location
- Yale University
Trial Purpose and Description
Eligibility Criteria
1. Treatment seeking subjects with Alcohol Use Disorder (AUD) meeting DSM-5 criteria as assessed by SCID by qualified medical staff and:
a. Consumed at least 4 binge drinking days (i.e. ≥ 5 standard drinks in a day for men or ≥ 4 standard drinks in a day for women) in the month prior to screening.
b. A desire to reduce or stop drinking.
2. Participants must be 18 to 60 years of age
3. Body mass index between 18 and 35, with a weight above 60 kg
4. No (history of) clinically significant conditions and concomitant medications which in the opinion of the investigator could endanger the safety of the subject or impact the validity of the study results,
5. Stable housing in the 3 months prior to screening with no foreseeable risk to lose this in the 3 months after screening,
6. Participants must agree to abstain from new/additional psychotropic medications, except for benzodiazepines as rescue medication prescribed by the PI or a stable dose of psychotropic medications in the 1-months14 days (or 5 half-lives; whichever is longer) prior to enrollment/randomization with the intention to continue this medication during the study.
7. Participants with no cannabis or other drug use for at least 5 half-lives prior to screening, including nicotine use (i.e., subjects must abstain from nicotine use for at least five half-lives prior to screening).
8. Participants with no history of seizures or epilepsy.
9. No current or past history of Major Depressive Disorder (MDD) (within past 1 years), Bipolar Disorder, Schizophrenia, suicidal ideation (within past 2 years) or suicide attempts in the past 2 years.
10. No participant who takes, or are planning to take, any prescription or non-prescription medications, within at least 14 days (or 5 half-lives; whichever is longer) prior to screening enrollment/randomization, and for the entire duration of the study including: a) antipsychotic and mood stabilizing medications (including SSRIs such as Fluoxetine and Paroxetine, SNRIs and trazodone), OCT1 and OCT2 substrates (such as Metformin, Cisplatin, Imatinib, Procainamide, Citalopram, Cimetidine, Quinidine), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or lithium, b) serotonin-acting herbal medicines and supplements, dietary supplements (such as 5- hydroxy-trypthophan or St. John Wort), and enzyme altering agents (such as and/or grapefruit juice and/or rifampin, barbiturates, phenothiazines, cimetidine, etc.) or any other medications that may have significant interaction with the study medication.
11. No Participant who received an experimental drug or used an experimental medical device within 1 month or within a period <5 times the drug’s half-life for small molecules, or 3 months for biologics, whichever is longer, before the study drug is administered for the first time.
