Back to resultsEffects of Cannabidiol in Alcohol Use Disorder
Primary Purpose
Alcohol Use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
Phytocannabinoid cannabidiol (CBD)
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Cannabidiol, Alcohol Use Disorder
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks
CBD for 8 weeks
Arm Description
600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).
600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).
Outcomes
Primary Outcome Measures
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Secondary Outcome Measures
Percentage of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Percent of Heavy Drinking Days
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Number of Drinks Per Day
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Penn Alcohol Craving Scale (PACS) Score
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Anxiety Inventory (BAI) Score
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Beck Depression Inventory (BDI) Score
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Full Information
NCT ID
NCT03252756
First Posted
August 14, 2017
Last Updated
April 10, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH), Tilray
1. Study Identification
Unique Protocol Identification Number
NCT03252756
Brief Title
Effects of Cannabidiol in Alcohol Use Disorder
Official Title
Effects of Cannabidiol in Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 16, 2022 (Actual)
Study Completion Date
March 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH), Tilray
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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). This double-blind, randomized proof-of-concept study (n = 40) is designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD to those of placebo in AUD patients. Participants with AUD will be randomized to receive either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and motoric function), and physiological and psychological domains relevant to AUD (including self-reported craving, depression, and anxiety, and responses to personalized scripts designed to elicit stress- and cue-induced craving and anxiety). Assessments will be conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs. placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
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 (CBD) has attracted considerable attention due to its lack of abuse potential, its excellent safety profile, its unique and complex pharmacology, and evidence that it affects anxiety and stress response in animal models and humans. There is a growing body of preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol self-administration and preference for alcohol, and alcohol-, cue- and stress-induced reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in humans with addictive disorders, and none in alcohol dependent patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Cannabidiol, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized proof-of-concept study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks
Arm Type
Experimental
Arm Description
600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).
Arm Title
CBD for 8 weeks
Arm Type
Experimental
Arm Description
600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline taken by mouth (PO)
Intervention Type
Drug
Intervention Name(s)
Phytocannabinoid cannabidiol (CBD)
Intervention Description
CBD taken by mouth (PO)
Primary Outcome Measure Information:
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Baseline
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Week 1
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Week 4
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Week 5
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Week 8
Title
Trough CBD Plasma Levels
Description
CBD "trough" plasma levels measured before dosing with CBD.
Time Frame
Week 9
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Baseline
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Day 1
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Week 1
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Week 4
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Week 4 + 1 Day
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Week 5
Title
Peak CBD Plasma Levels
Description
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Baseline
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 1
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 2
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 3
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 4
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 5
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 6
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 7
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 8
Title
Percent of Heavy Drinking Days
Description
The percent of heavy drinking days will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of days in the past 7 days in which they drank heavily.
Time Frame
Week 9
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Baseline
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 1
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 2
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 3
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 4
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 5
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 6
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 7
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 8
Title
Number of Drinks Per Day
Description
The number of drinks per day will be assessed by Timeline Follow Back (TLFB) methodology over the previous week. The TLFB methodology allows participants to report the number of drinks per day over the last 7 days.
Time Frame
Week 9
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Baseline
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Week 1
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Week 4
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Week 5
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Week 8
Title
Penn Alcohol Craving Scale (PACS) Score
Description
5-item self-report measure of alcohol craving. Items are ranked on a Likert scale ranging from 0 (not at all) to 6 (severely). The total score is a sum of all the responses and ranges from 0 to 30. Higher scores indicate greater alcohol craving.
Time Frame
Week 9
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Baseline
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Week 1
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Week 4
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Week 5
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Week 8
Title
Beck Anxiety Inventory (BAI) Score
Description
21-item self-report measure of anxiety. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of anxiety. Scores are interpreted as follows: 0 - 21 = low anxiety; 22 - 35 = moderate anxiety; 36 and above = potentially concerning levels of anxiety.
Time Frame
Week 9
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Baseline
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Week 1
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Week 4
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Week 5
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Week 8
Title
Beck Depression Inventory (BDI) Score
Description
21-item self-report measure of depression. Items are ranked on a Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score is the sum of responses and ranges from 0 to 63, where higher scores indicate greater levels of depression. Scores are interpreted as follows: 0 - 10 = normal ups and downs; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; over 40 = extreme depression.
Time Frame
Week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bogenschutz, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal with have access to the data. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Effects of Cannabidiol in Alcohol Use Disorder
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