Status:
COMPLETED
Effects of Cannabidiol in Alcohol Use Disorder
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Institutes of Health (NIH)
Tilray
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of the proposed project is to begin rigorous study of the clinically relevant effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe alcohol use disorder (AUD)...
Detailed Description
There is increasing recognition of the roles of the endocannabinoid system in neurobiological processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid cannabidiol ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03252756
Start Date
September 1 2019
End Date
March 16 2022
Last Update
May 3 2023
Active Locations (1)
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1
New York University School of Medicine
New York, New York, United States, 10016