Cannabidiol as a Treatment for AUD Comorbid With PTSD
Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
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, 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Cannabidiol (CBD 600 mg daily)
6 weeks, such that both participants and study staff are blind to treatment condition.
|
600 mg daily
Other Names:
|
|
Placebo Comparator: Placebo
6 weeks, such that both participants and study staff are blind to treatment condition.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Week 4
|
|
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.
|
Week 6
|
|
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.
|
Baseline
|
|
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.
|
Week 4
|
|
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.
|
Week 6
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Carbohydrate Deficient Transferrin (CDT)
Time Frame: Baseline
|
CDT test performed on blood sample
|
Baseline
|
|
Percent Carbohydrate Deficient Transferrin (CDT)
Time Frame: Week 4
|
CDT test performed on blood sample
|
Week 4
|
|
Percent Carbohydrate Deficient Transferrin (CDT)
Time Frame: Week 6
|
CDT test performed on blood sample
|
Week 6
|
|
Percentage of Heavy Drinking Days
Time Frame: Baseline
|
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.
|
Baseline
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 1
|
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.
|
Week 1
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 2
|
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.
|
Week 2
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 3
|
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.
|
Week 3
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 4
|
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.
|
Week 4
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 5
|
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.
|
Week 5
|
|
Percentage of Heavy Drinking Days
Time Frame: Week 6
|
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.
|
Week 6
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Baseline
|
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.
|
Baseline
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 1
|
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.
|
Week 1
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 3
|
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.
|
Week 3
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 4
|
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.
|
Week 4
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 5
|
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.
|
Week 5
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 6
|
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.
|
Week 6
|
|
Percentage of Days Abstinent
Time Frame: Baseline
|
Baseline
|
|
|
Percentage of Days Abstinent
Time Frame: Week 1
|
Week 1
|
|
|
Percentage of Days Abstinent
Time Frame: Week 2
|
Week 2
|
|
|
Percentage of Days Abstinent
Time Frame: Week 3
|
Week 3
|
|
|
Percentage of Days Abstinent
Time Frame: Week 4
|
Week 4
|
|
|
Percentage of Days Abstinent
Time Frame: Week 5
|
Week 5
|
|
|
Percentage of Days Abstinent
Time Frame: Week 6
|
Week 6
|
|
|
Percentage of Very Heavy Drinking Days
Time Frame: Week 2
|
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.
|
Week 2
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Baseline
|
Baseline
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 1
|
Week 1
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 2
|
Week 2
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 3
|
Week 3
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 4
|
Week 4
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 5
|
Week 5
|
|
|
Number of Participants With No Heavy Drinking Days
Time Frame: Week 6
|
Week 6
|
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Baseline
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Baseline
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 1
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 1
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 2
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 2
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 3
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 3
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 4
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 4
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 5
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 5
|
|
Number of Participants That Are 'Present and Clear'
Time Frame: Week 6
|
Present is defined as present to provide breath alcohol levels (BAC).
Clear is defined as having a BAC of zero.
|
Week 6
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Charles Marmar, MD, New York University Grossman School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 17-00949
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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