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New treatment option for Alcohol Use Disorder
Official title A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
ClinicalTrials.gov ID: NCT05913752
What this study is testing
What is CMND-100?
CMND-100 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcohol use disorder.
Also referred to as MEAI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- All people
- Signed informed consent prior to any study-related procedures,
- people understand the nature and the procedures related with the study design of the trial and accept to fulfill all activities related to this trial,
- people 18 to 60 years of age,
- Body mass index between 18 and 35 kg/m2, with a weight above 60 kg.
You likely can't join if
- All people
- The subject has a clinically significant history of a disease or a disorder that could interfere with the interpretation of the results or could...
- Subject has a substance use disorder at time of screening (except for alcohol use in AUD people and nicotine use disorders),
- people with cannabis or other drug use for at least 5 half-lives prior to screening, including nicotine use (i.e., people must abstain from nicotine...
- people with symptoms of alcohol withdrawal or intoxication at time of screening (assessed using CIWA-Ar tool). if medically appropriate, intoxicated...
- people with history of seizures or epilepsy,
See the full eligibility criteria
- All people
- Signed informed consent prior to any study-related procedures,
- people understand the nature and the procedures related with the study design of the trial and accept to fulfill all activities related to this trial,
- people 18 to 60 years of age,
- Body mass index between 18 and 35 kg/m2, with a weight above 60 kg.
- 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 people 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 people 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 people of childbearing potential (less than 24 months after the last menstrual cycle) who use adequate contraceptive methods. Adequate contraceptive methods may include any approved method of birth control such...
- 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.
- A desire to reduce or stop drinking.
- Stable housing in the 3 months prior to screening with no foreseeable risk to lose this in the 3 months after screening,
- 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 14 days (or 5 half-lives; whichever...
- All people
- The subject has a clinically significant history of a disease or a disorder that could interfere with the interpretation of the results or could increase the risk to the subject all according to the opinion of the PI,
- Subject has a substance use disorder at time of screening (except for alcohol use in AUD people and nicotine use disorders),
- people with cannabis or other drug use for at least 5 half-lives prior to screening, including nicotine use (i.e., people must abstain from nicotine use for at least five half-lives prior to screening).
- people with symptoms of alcohol withdrawal or intoxication at time of screening (assessed using CIWA-Ar tool). if medically appropriate, intoxicated individuals will be provided transportation home while those...
- people with history of seizures or epilepsy,
- 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,
- Uncontrolled inter-current illness (i.e., active infection),
- Clinically significant abnormal vital signs (e.g., systolic blood pressure ≥139 mmHg, diastolic blood pressure ≥90 mmHg, heart rate \>90 beats per minute) at separate three measures before dosing,
- Clinically significant abnormal ECG parameters, including people with QTc greater than 450 msec.
- Clinically significant abnormal liver functions (ALT and AST), higher than three times the upper normal amount, clinically significant abnormal Hb, and/or clinically significant laboratory abnormalities (e.g., abnormal...
- people who take, 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 enrollment/randomization, and for the entire duration...
- 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...
- Donated blood within 90 days or plasma within 30 days of study dosing,
- Any subject who may not be able to fulfill the study requirements per the investigator's clinical judgement. Additional Criteria for Healthy people
- Subject is unable to abstain from ingesting alcohol for 72 hours prior to dosing.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Baltimore, Maryland, United States
- Jerusalem, Israel
- Tel Aviv, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Baltimore, Maryland, United States; Jerusalem, Israel; Tel Aviv, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.