Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT07279558
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 21-65
2. Provides informed consent to participate
3. Meets the following cannabis use criteria:
* Are not CBD or THC naïve: have used CBD or a cannabis product containing CBD at least once in the last year and have used THC or a cannabis product containing THC at least once in the last year
* Are not frequent cannabis users (those who use cannabis 6 or more times per month over the past 3 months will be excluded)
4. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms)
5. Meets the following drinking criteria:
* Must have consumed alcohol at least 2x per week, with a minimum of 20 drinks per week (for both males and females), consistently for the past three months.
* Must report at least 1 heavy drinking day per week over the past 3 months (5 or more drinks per day for males, 4 or more drinks per day for females)
6. Willing to provide fecal samples
7. Willing to have their blood drawn
8. Able to attend in-person visits at the study site
Exclusion Criteria:
1. Must not currently take any of the following medications:
* Those known to have a major interaction with Epidiolex
* Those known to have a major interaction with Marinol
* Acute treatment with any antiepileptic medications
* Acute treatment with any psychotropic medications besides antidepressants (Note participants using antidepressants must be on a stable dose for the past 90 days and should not require medication adjustments during the study period. Those who do not meet these criteria will be excluded).
* Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate, etc.)
2. Females must not be pregnant, nursing, nor planning a pregnancy. Individuals not using contraception or practicing abstinence will also be excluded
3. Must not be positive for any illicit drugs (besides cannabis) on urine drug screen or self- report any illicit/recreational drug use in the past 30 days.
4. Must not have a history of a serious DSM-V psychiatric disorder, including bipolar affective disorder, schizophrenia, cluster B personality disorders (borderline, antisocial, histrionic, narcissistic), or any other psychotic mental disorder. Must not have a current diagnosis of an eating disorder, panic disorder, obsessive/compulsive disorder, or post-traumatic stress disorder.
5. Must not meet criteria for a medical condition that contraindicates the use of CBD
6. Must not have clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion
7. Must not report a history of alcohol-related liver disease or alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer
• We will evaluate hepatocellular disease throughout the study (Baseline, Week 4, Week 8, and Week 12 Visits), subjects with elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than two times the upper limit of the normal range will be withdrawn and referred for medical treatment.
8. Must not have used antibiotics in the past three months
9. Must not have ever been diagnosed with a gastrointestinal disorder
10. Must not have used probiotic supplements in the past one month.
11. Must not be seeking treatment/in treatment for AUD or another substance use disorder.
12. Must not have a history of severe alcohol withdrawal (e.g., seizure, delirium tremens)
• Assessed via self-report during screening and with the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) at the Baseline, Medication Dispense, Week 4, Week 8, and Week 12 study visits. Subjects who score greater than 7 on the CIWA-Ar will be withdrawn and referred for medical treatment.
13. Must not have a current diagnosis of a substance use disorder besides AUD (note: cannabis use disorder is also exclusionary)
14. Current suicidality risk as indicated during the conduct of the C-SSRS with concurrence after a study physician's or PI evaluation if the response to C-SSRS questions 1 or 2 is "yes"
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT07279558
Study Brief:
Protocol Section:
NCT07279558