Alcohol Use DisorderPhase 1/2NCT03248167
Cannabidiol as a Treatment for AUD Comorbid With PTSD
A Phase 1/2 study testing Cannabidiol in people with Alcohol Use Disorder and Post Traumatic Stress Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder, Post Traumatic Stress Disorder
- What is being tested?
- Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 20 Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females age 18-70
- DSM-5 diagnosis of moderate or severe AUD
- DSM-5 diagnosis of PTSD with Clinician Administered PTSD Scale (CAPS-5) OR subPTSD diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria B-E) with Clinician Administered PTSD Scale (CAPS-5)
- Able to provide voluntary informed consent
- At least 6 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day 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
Show all 10Show fewer
- Able to provide at least two locators
- Endorse desire to cut down or stop drinking
- Agrees to abstain from all other cannabinoid use for the duration of the study
- Confirms they are reliably domiciled
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, and/or an inability to understand study procedures or the informed consent process, based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)
- Exposure to trauma in the last 30 days, including police duty or military service
- Current significant suicidality (assessed using the C-SSRS), any significant suicidal behavior in the past 12 months, or any history of serious suicide attempts requiring hospitalization, or current significant homicidality
Show all 16Show fewer
- History of Severe Traumatic Brain Injury (TBI; as indicated by Loss of Consciousness > 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 but not limited to cannabinoids; those acting on serotonergic pathways; 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.
- Current treatment for AUD (with exceptions of: AA/12-step treatment and/or psychosocial treatment initiated more than 3 months prior to the screening visit)
- Psychotherapy for PTSD or other psychiatric condition, if initiated within 3 months of screening
- Inpatient psychiatric treatment in the last 12 months, with the exception of detox and extended Emergency Department stays
- A positive urine drug screen for opioids at screen, baseline, or any later visits. If a participant has a positive drug screen for THC or cocaine at screen, baseline or a later visit- their enrollment will be subject to the clinical judgement of the Principal Investigator.
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
Official title: Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder
This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.
Read the detailed description
In this project, investigators aim to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research focus because it shows promise for treating anxiety and other brain disorders, but does not produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is safe, with few or no side effects. AUD, which is one of the most common and most debilitating psychiatric conditions, is often associated with other comorbid psychiatric disorders - in particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further, evidence shows that the brain circuits underlying negative emotion and addiction are linked in a forebrain area called the extended amygdala, which provides a neuropharmacological target to simultaneously treat both negative emotion and alcohol addiction in individuals with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol seeking in animal models.
- Being tested
- Cannabidiol, Placebos
- Keywords
- Cannabidiol
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called CBD
600 mg daily
PlacebosDrug
This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD 600 mg daily) | Experimental | 6 weeks, such that both participants and study staff are blind to treatment condition. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | 6 weeks, such that both participants and study staff are blind to treatment condition. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinks Per Day
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
Measured: Baseline
Number of Drinks Per Day
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
Measured: Week 4
Number of Drinks Per Day
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
Measured: Week 6
PCL-5 Total Score
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
Measured: Baseline
PCL-5 Total Score
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
Measured: Week 4
PCL-5 Total Score
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
Measured: Week 6
Secondary outcomes (38)
Percent Carbohydrate Deficient Transferrin (CDT)
CDT test performed on blood sample
Measured: Baseline
Percent Carbohydrate Deficient Transferrin (CDT)
CDT test performed on blood sample
Measured: Week 4
Percent Carbohydrate Deficient Transferrin (CDT)
CDT test performed on blood sample
Measured: Week 6
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Baseline
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 1
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 2
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 3
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 4
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 5
Percentage of Heavy Drinking Days
Heavy drinking days is defined as 4+ drinks for women or five or more drinks for men per drinking day. This will be averaged for each treatment week.
Measured: Week 6
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Baseline
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 1
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 2
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 3
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 4
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 5
Percentage of Very Heavy Drinking Days
Very heavy drinking days is defined as 8+/10+ drinks per day for women and men respectively. This will be averaged for each treatment week.
Measured: Week 6
Number of Participants With No Heavy Drinking Days
Measured: Baseline
Number of Participants With No Heavy Drinking Days
Measured: Week 1
Number of Participants With No Heavy Drinking Days
Measured: Week 2
Number of Participants With No Heavy Drinking Days
Measured: Week 3
Number of Participants With No Heavy Drinking Days
Measured: Week 4
Number of Participants With No Heavy Drinking Days
Measured: Week 5
Number of Participants With No Heavy Drinking Days
Measured: Week 6
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Baseline
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 1
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 2
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 3
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 4
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 5
Number of Participants That Are 'Present and Clear'
Present is defined as present to provide breath alcohol levels (BAC). Clear is defined as having a BAC of zero.
Measured: Week 6
Percentage of Days Abstinent
Measured: Baseline
Percentage of Days Abstinent
Measured: Week 1
Percentage of Days Abstinent
Measured: Week 2
Percentage of Days Abstinent
Measured: Week 3
Percentage of Days Abstinent
Measured: Week 4
Percentage of Days Abstinent
Measured: Week 5
Percentage of Days Abstinent
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start16 Sep 2019
- Primary completion20 Apr 2022
- Study completion20 Apr 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 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
- Charles Marmar, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248167
- Sponsor's protocol ID
- 17-00949
- Status last verified
- Jun 2023
- First submitted
- 2 Aug 2017
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, Scicluna RL, Everett NA, Bowen MT, James MH. Emerging medications and pharmacological treatment approaches for substance use disorders. Pharmacol Biochem Behav. 2025 Mar;248:173952. doi: 10.1016/j.pbb.2024.173952. Epub 2024 Dec 22.
PubMed 39719161
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03248167
- Acronym / sponsor ID
- 17-00949
- Keywords
- Cannabidiol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Tilray
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to determine whether cannabidiol (CBD), a compound derived from the cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. Participants (each treated for 6 weeks) will be continuously recruited over a study period of 14 months until 48 have completed. Baseline and weekly data will be collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD treatment leads to a greater improvement in these measures relative to placebo, and whether reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects will also participate in a task designed to quantify the psychological and physiological links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving. The task will be administered following 4 weeks of treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated negative emotion between CBD and placebo groups will be compared. This study will be the first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in humans, and the first to examine the interaction between these treatment effects. Results will serve as proof of concept and provide guidance for a future larger clinical trial. Because CBD is a safe, readily available drug, such a trial would have an immense potential to prevent death, medical illness, and psychological suffering associated with AUD and PTSD. Further, because the brain circuits via which CBD acts to produce hypothesized effects are relatively well-understood, results may substantially advance understanding of the neurobiological basis of alcohol addiction.
Detailed description
In this project, investigators aim to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research focus because it shows promise for treating anxiety and other brain disorders, but does not produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is safe, with few or no side effects. AUD, which is one of the most common and most debilitating psychiatric conditions, is often associated with other comorbid psychiatric disorders - in particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further, evidence shows that the brain circuits underlying negative emotion and addiction are linked in a forebrain area called the extended amygdala, which provides a neuropharmacological target to simultaneously treat both negative emotion and alcohol addiction in individuals with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol seeking in animal models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD 600 mg daily) | Experimental | Drug: Cannabidiol6 weeks, such that both participants and study staff are blind to treatment condition. |
| Placebo | Placebo comparator | Drug: Placebos6 weeks, such that both participants and study staff are blind to treatment condition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females age 18-70
- DSM-5 diagnosis of moderate or severe AUD
- DSM-5 diagnosis of PTSD with Clinician Administered PTSD Scale (CAPS-5) OR subPTSD diagnosis (meeting criterion A, F, G, H and at least 6 symptoms across any criteria B-E) with Clinician Administered PTSD Scale (CAPS-5)
- Able to provide voluntary informed consent
- At least 6 heavy drinking days (4 or more drinks per day for a woman, 5 or more drinks per day for a man) in the 30 days prior to screen
Key exclusion criteria (16 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, and/or an inability to understand study procedures or the informed consent process, based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support)
- Exposure to trauma in the last 30 days, including police duty or military service
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 |
|---|---|---|
| CannabidiolAlso: CBD600 mg daily | Drug | Cannabidiol (CBD 600 mg daily) |
| PlacebosThis project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be administered to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition. | Drug | Placebo |
Primary outcome
Number of Drinks Per Day
Time frame: Baseline
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
Number of Drinks Per Day
Time frame: Week 4
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
Number of Drinks Per Day
Time frame: Week 6
Number of drinks per day will be assessed by the Time Line Follow Back (TLFB) methodology. TLFB is a drinking assessment method that can be administered in various formats: as clinician-administered interview, paper and pencil and computer. TLFB is used to obtain estimates of the quantity of daily drinking.
PCL-5 Total Score
Time frame: Baseline
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
PCL-5 Total Score
Time frame: Week 4
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
PCL-5 Total Score
Time frame: Week 6
The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.
38 secondary outcomes
Percent Carbohydrate Deficient Transferrin (CDT)
Time frame: Baseline
Percent Carbohydrate Deficient Transferrin (CDT)
Time frame: Week 4
Percent Carbohydrate Deficient Transferrin (CDT)
Time frame: Week 6
Percentage of Heavy Drinking Days
Time frame: Baseline
Percentage of Heavy Drinking Days
Time frame: Week 1
Percentage of Heavy Drinking Days
Time frame: Week 2
Percentage of Heavy Drinking Days
Time frame: Week 3
Percentage of Heavy Drinking Days
Time frame: Week 4
Percentage of Heavy Drinking Days
Time frame: Week 5
Percentage of Heavy Drinking Days
Time frame: Week 6
Percentage of Very Heavy Drinking Days
Time frame: Baseline
Percentage of Very Heavy Drinking Days
Time frame: Week 1
Percentage of Very Heavy Drinking Days
Time frame: Week 2
Percentage of Very Heavy Drinking Days
Time frame: Week 3
Percentage of Very Heavy Drinking Days
Time frame: Week 4
Percentage of Very Heavy Drinking Days
Time frame: Week 5
Percentage of Very Heavy Drinking Days
Time frame: Week 6
Number of Participants With No Heavy Drinking Days
Time frame: Baseline
Number of Participants With No Heavy Drinking Days
Time frame: Week 1
Number of Participants With No Heavy Drinking Days
Time frame: Week 2
Number of Participants With No Heavy Drinking Days
Time frame: Week 3
Number of Participants With No Heavy Drinking Days
Time frame: Week 4
Number of Participants With No Heavy Drinking Days
Time frame: Week 5
Number of Participants With No Heavy Drinking Days
Time frame: Week 6
Number of Participants That Are 'Present and Clear'
Time frame: Baseline
Number of Participants That Are 'Present and Clear'
Time frame: Week 1
Number of Participants That Are 'Present and Clear'
Time frame: Week 2
Number of Participants That Are 'Present and Clear'
Time frame: Week 3
Number of Participants That Are 'Present and Clear'
Time frame: Week 4
Number of Participants That Are 'Present and Clear'
Time frame: Week 5
Number of Participants That Are 'Present and Clear'
Time frame: Week 6
Percentage of Days Abstinent
Time frame: Baseline
Percentage of Days Abstinent
Time frame: Week 1
Percentage of Days Abstinent
Time frame: Week 2
Percentage of Days Abstinent
Time frame: Week 3
Percentage of Days Abstinent
Time frame: Week 4
Percentage of Days Abstinent
Time frame: Week 5
Percentage of Days Abstinent
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39719161Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, Scicluna RL, Everett NA, Bowen MT, James MH. Emerging medications and pharmacological treatment approaches for substance use disorders. Pharmacol Biochem Behav. 2025 Mar;248:173952. doi: 10.1016/j.pbb.2024.173952. Epub 2024 Dec 22.
- Individual participant dataSharing planned: Undecided
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Alcohol Use Disorder
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.
Charles Marmar, MD 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 Cannabidiol in people with Alcohol Use Disorder and Post Traumatic Stress 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 10 inclusion and 16 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 28 Jun 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. Some participants in this study may receive a placebo. 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 28 Jun 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?
Number of Drinks Per Day (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248167, which also lists 1 linked publication.
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 28 Jun 2023.