Alcohol Use DisorderPhase 1/2NCT03252756
Effects of Cannabidiol in Alcohol Use Disorder
A Phase 1/2 study testing Phytocannabinoid cannabidiol (CBD) in people with Alcohol Use Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Phytocannabinoid cannabidiol (CBD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 16 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Placebo, Phytocannabinoid cannabidiol (CBD)
- Keywords
- Cannabidiol, Alcohol Use Disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Saline taken by mouth (PO)
Phytocannabinoid cannabidiol (CBD)Drug
CBD taken by mouth (PO)
| Study group | Role | What they receive |
|---|---|---|
| Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks | Experimental | 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). Receives: Other: Placebo |
| CBD for 8 weeks | Experimental | 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). Receives: Drug: Phytocannabinoid cannabidiol (CBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Baseline
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Week 1
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Week 4
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Week 5
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Week 8
Trough CBD Plasma Levels
CBD "trough" plasma levels measured before dosing with CBD.
Measured: Week 9
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Baseline
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Day 1
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Week 1
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Week 4
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Week 4 + 1 Day
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Week 5
Peak CBD Plasma Levels
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Measured: Week 8
Secondary outcomes (38)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 5
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Sep 2019
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized proof-of-concept study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Tilray
- Responsible party
- Sponsor
- Investigators
- Michael Bogenschutz, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252756
- Sponsor's protocol ID
- 17-01001
- Status last verified
- Apr 2023
- First submitted
- 14 Aug 2017
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cannabidiol in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03252756
- Acronym / sponsor ID
- 17-01001
- Conditions
- Alcohol Use Disorder
- Keywords
- Cannabidiol, Alcohol Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Tilray
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double-blind, randomized proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks | Experimental | Other: Placebo600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks). |
| CBD for 8 weeks | Experimental | Drug: Phytocannabinoid cannabidiol (CBD)600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO) for an additional 4 weeks (8 total weeks). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSaline taken by mouth (PO) | Other | Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks |
| Phytocannabinoid cannabidiol (CBD)CBD taken by mouth (PO) | Drug | CBD for 8 weeks |
Primary outcome
Trough CBD Plasma Levels
Time frame: Baseline
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
Time frame: Week 1
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
Time frame: Week 4
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
Time frame: Week 5
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
Time frame: Week 8
CBD "trough" plasma levels measured before dosing with CBD.
Trough CBD Plasma Levels
Time frame: Week 9
CBD "trough" plasma levels measured before dosing with CBD.
Peak CBD Plasma Levels
Time frame: Baseline
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Day 1
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Week 1
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Week 4
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Week 4 + 1 Day
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Week 5
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
Peak CBD Plasma Levels
Time frame: Week 8
CBD "peak" plasma levels measured 45 minutes after dosing with CBD.
38 secondary outcomes
Percentage of Heavy Drinking Days
Time frame: Baseline
Percent of Heavy Drinking Days
Time frame: Week 1
Percent of Heavy Drinking Days
Time frame: Week 2
Percent of Heavy Drinking Days
Time frame: Week 3
Percent of Heavy Drinking Days
Time frame: Week 4
Percent of Heavy Drinking Days
Time frame: Week 5
Percent of Heavy Drinking Days
Time frame: Week 6
Percent of Heavy Drinking Days
Time frame: Week 7
Percent of Heavy Drinking Days
Time frame: Week 8
Percent of Heavy Drinking Days
Time frame: Week 9
Number of Drinks Per Day
Time frame: Baseline
Number of Drinks Per Day
Time frame: Week 1
Number of Drinks Per Day
Time frame: Week 2
Number of Drinks Per Day
Time frame: Week 3
Number of Drinks Per Day
Time frame: Week 4
Number of Drinks Per Day
Time frame: Week 5
Number of Drinks Per Day
Time frame: Week 6
Number of Drinks Per Day
Time frame: Week 7
Number of Drinks Per Day
Time frame: Week 8
Number of Drinks Per Day
Time frame: Week 9
Penn Alcohol Craving Scale (PACS) Score
Time frame: Baseline
Penn Alcohol Craving Scale (PACS) Score
Time frame: Week 1
Penn Alcohol Craving Scale (PACS) Score
Time frame: Week 4
Penn Alcohol Craving Scale (PACS) Score
Time frame: Week 5
Penn Alcohol Craving Scale (PACS) Score
Time frame: Week 8
Penn Alcohol Craving Scale (PACS) Score
Time frame: Week 9
Beck Anxiety Inventory (BAI) Score
Time frame: Baseline
Beck Anxiety Inventory (BAI) Score
Time frame: Week 1
Beck Anxiety Inventory (BAI) Score
Time frame: Week 4
Beck Anxiety Inventory (BAI) Score
Time frame: Week 5
Beck Anxiety Inventory (BAI) Score
Time frame: Week 8
Beck Anxiety Inventory (BAI) Score
Time frame: Week 9
Beck Depression Inventory (BDI) Score
Time frame: Baseline
Beck Depression Inventory (BDI) Score
Time frame: Week 1
Beck Depression Inventory (BDI) Score
Time frame: Week 4
Beck Depression Inventory (BDI) Score
Time frame: Week 5
Beck Depression Inventory (BDI) Score
Time frame: Week 8
Beck Depression Inventory (BDI) Score
Time frame: Week 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bogenschutz, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Phytocannabinoid cannabidiol (CBD) in people with Alcohol Use Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough CBD Plasma Levels (time frame: Baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.