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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Saline taken by mouth (PO)
CBD taken by mouth (PO)
New York University School of Medicine
New York, New York, United States
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Baseline
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Week 1
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Week 4
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Week 5
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Week 8
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Time frame: Week 9
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Baseline
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Day 1
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Week 1
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Week 4
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Week 4 + 1 Day
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Week 5
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Time frame: Week 8
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.
Time frame: Baseline
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.
Time frame: Week 1
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.
Time frame: Week 2
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.
Time frame: Week 3
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.
Time frame: Week 4
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.
Time frame: Week 5
Percent of Heavy Drinking Days
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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
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.
Time frame: Week 7
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.
Time frame: Week 8
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.
Time frame: Week 9
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.
Time frame: Baseline
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.
Time frame: Week 1
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.
Time frame: Week 2
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.
Time frame: Week 3
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.
Time frame: Week 4
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.
Time frame: Week 5
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.
Time frame: Week 6
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.
Time frame: Week 7
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.
Time frame: Week 8
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.
Time frame: Week 9
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.
Time frame: Baseline
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.
Time frame: Week 1
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.
Time frame: Week 4
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.
Time frame: Week 5
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.
Time frame: Week 8
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.
Time frame: Week 9
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.
Time frame: Baseline
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.
Time frame: Week 1
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.
Time frame: Week 4
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.
Time frame: Week 5
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.
Time frame: Week 8
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.
Time frame: Week 9
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.
Time frame: Baseline
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.
Time frame: Week 1
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.
Time frame: Week 4
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.
Time frame: Week 5
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.
Time frame: Week 8
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.
Time frame: Week 9