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:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03252756
Eligibility Criteria:
Inclusion Criteria:
* Males and females age 18-65
* DSM-5 diagnosis of moderate or severe AUD
* Able to provide voluntary informed consent
* At least 8 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen
* If of childbearing potential (male or female), are willing to use approved form of contraception from screening for duration of the trial
* Able to provide at least two locators
* Endorse desire to cut down or stop drinking
* Agrees to abstain from all other cannabinoid use for duration of the study
Exclusion Criteria:
* Current alcohol withdrawal (CIWA-Ar score \>7)
* Exclusionary medical conditions (e.g. current severe alcohol withdrawal requiring medical hospitalization, significantly impaired liver function)
* DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder
* High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)
* Current significant suicidality (assessed using the C-SSRS), any suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidality
* History of severe Traumatic Brain Injury (LOC \> 24 hours)
* DSM-5 diagnosis of current mild cannabis use disorder and/or moderate or severe substance use disorder for a substance other than alcohol or nicotine
* Significant laboratory abnormalities, including significantly impaired liver function, serious abnormalities of complete blood count or metabolic panel
* Active legal problems likely to result in incarceration within 12 weeks of treatment initiation
* Pregnancy or lactation
* Current use of exclusionary medications, including cannabinoids; treatments for addictions including alcohol; moderate to strong inhibitors of CYP3A4 or CYP2C19; medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7; and medications with a narrow therapeutic index which are substrates of UGT1A9, UGT2B7, CYP2C8, CYP2C9, CYP2C19, CYP1A2, or CYP2B6.
* Allergy to any ingredient of the study compound.
* Current treatment for AUD, with exception of AA/12-step treatment
* No inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays
* A positive urine drug screen for THC, cocaine and/or opioids at screen
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03252756
Study Brief:
Protocol Section:
NCT03252756