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Cannabidiol as a Treatment for AUD Comorbid With PTSD

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ClinicalTrials.gov Identifier: NCT03248167
Recruitment Status : Not yet recruiting
First Posted : August 14, 2017
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 14, 2017
Last Update Posted Date May 15, 2019
Estimated Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
Number of drinks per day [ Time Frame: Baseline to 6 Weeks ]
Number of drinks per day will be assessed with the Time Line Follow Back scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03248167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • Weekly percentage of heavy drinking days [ Time Frame: Baseline to 6 Weeks ]
    Percentage of heavy drinking days will be assessed with the Time Line Follow Back scale. specifically the number of days (per week) on which number of drinks consumed exceeds four or more drinks for women, and five or more drinks for men.
  • Weekly percentage of very heavy drinking days [ Time Frame: Baseline to 6 Weeks ]
    Percentage of very heavy drinking days will be assessed with the Time Line Follow Back scale, specifically the number of days (per week) on which number of drinks consumed exceeds eight drinks for women, and ten drinks for men.
  • Weekly percentage of subjects that are present and clean [ Time Frame: Baseline to 6 Weeks ]
    The percentage of subjects per week that are present to provide a breath alcohol level, and have a breath alcohol level of zero.
  • Weekly percentage of days abstinent [ Time Frame: Baseline to 6 Weeks ]
    Percentage of days abstinent will be assessed with the Time Line Follow Back scale, specifically the number of days (per week) on which no drinks are consumed.
  • Weekly average severity of alcohol craving [ Time Frame: Baseline to 6 Weekshe Penn Alcohol Craving scale, averaged across days for each week. ]
    Alcohol craving will be assessed daily with the Penn Alcohol Craving scale, averaged across days for each week.
  • PTSD symptoms [ Time Frame: Baseline to 6 Weeks ]
    PTSD symptoms will be assessed with the PTSD Checklist for the DSM-5 (PCL-5). Baseline PTSD symptoms will be defined as the total PCL-5 score at baseline. The primary PTSD outcome is the total score of the PCL-5 for each treatment week.
  • Psychophysiological Arousal related heart rate [ Time Frame: 4 weeks ]
    Psychophysiological Arousal will be derived from heart rate acquired during performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Psychophysiological Arousal related skin conductance [ Time Frame: 4 weeks ]
    Psychophysiological Arousal will be derived from skin conductance acquired during performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Trauma induced craving [ Time Frame: 4 weeks ]
    Alcohol craving induced by trauma related stress will be measured with the Alcohol Urge questionaire following performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Trauma induced negative emotion [ Time Frame: 4 weeks ]
    Negative emotion induced by trauma related stress will be measured with the Visual Analogue scale-Anxiety following performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • Weekly percentage of heavy drinking days [ Time Frame: Baseline to 6 Weeks ]
    Percentage of heavy drinking days will be assessed with the Time Line Follow Back scale. specifically the number of days (per week) on which number of drinks consumed exceeds four or more drinks for women, and five or more drinks for men.
  • Weekly percentage of very heavy drinking days [ Time Frame: Baseline to 6 Weeks ]
    Percentage of very heavy drinking days will be assessed with the Time Line Follow Back scale, specifically the number of days (per week) on which number of drinks consumed exceeds eight drinks for women, and ten drinks for men.
  • Weekly percentage of subjects that are present and clean [ Time Frame: Baseline to 6 Weeks ]
    The percentage of subjects per week that are present to provide a breath alcohol level, and have a breath alcohol level of zero.
  • Weekly percentage of days abstinent [ Time Frame: Baseline to 6 Weeks ]
    Percentage of days abstinent will be assessed with the Time Line Follow Back scale, specifically the number of days (per week) on which no drinks are consumed.
  • Weekly average severity of alcohol craving [ Time Frame: Baseline to 6 Weekshe Penn Alcohol Craving scale, averaged across days for each week. ]
    Alcohol craving will be assessed daily with the Penn Alcohol Craving scale, averaged across days for each week.
  • PTSD symptoms [ Time Frame: Baseline to 6 Weeks ]
    PTSD symptoms will be assessed with the PTSD Checklist for the DSM-5 (PCL-5). Baseline PTSD symptoms will be defined as the total PCL-5 score at baseline. The primary PTSD outcome is the total score of the PCL-5 for each treatment week.
  • Psychophysiological Arousal related heart rate [ Time Frame: Baseline to 6 Weeks ]
    Psychophysiological Arousal will be derived from heart rate acquired during performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Psychophysiological Arousal related skin conductance [ Time Frame: Baseline to 6 Weeks ]
    Psychophysiological Arousal will be derived from skin conductance acquired during performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Trauma induced craving [ Time Frame: Baseline to 6 Weeks ]
    Alcohol craving induced by trauma related stress will be measured with the Alcohol Urge questionaire following performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
  • Trauma induced negative emotion [ Time Frame: Baseline to 6 Weeks ]
    Negative emotion induced by trauma related stress will be measured with the Visual Analogue scale-Anxiety following performance of a Trauma induced craving task. The task assesses the response to three successive ~5-minute guided imagery scripts with one of three different conditions: Trauma, Stress, or Neutral. Personalized trauma and stress scripts will be developed in a separate ~ 2-hour session. Scripts are presented via audio headphones over a ~2-hour session in counterbalanced order, with neutral always in the middle. Investigators will assess response to Trauma, compared to Neutral conditions; however, the Stress condition will be kept to preserve task structure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol as a Treatment for AUD Comorbid With PTSD
Official Title  ICMJE Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder
Brief 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). 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Use Disorder
  • Post Traumatic Stress Disorder
Intervention  ICMJE
  • Drug: Cannabidiol
    600 mg daily
    Other Name: CBD
  • Drug: Placebos
    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 adminstred 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 Arms  ICMJE
  • Experimental: Cannabidiol (CBD 600 mg daily)
    6 weeks, such that both participants and study staff are blind to treatment condition.
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    6 weeks, such that both participants and study staff are blind to treatment condition.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 13, 2019)
48
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2017)
50
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-5 diagnosis of moderate or severe AUD
  • At least 10 heavy drinking days in the month prior to screening, as assessed by the Time Line Follow Back (TLFB)
  • At least 3 heavy drinking days in the two weeks between screening and baseline (TLFB);
  • DSM-5 diagnosis of PTSD, with a Clinician Administered PTSD Scale (CAPS) current symptom score > 25
  • Able to provide voluntary informed consent.

Exclusion Criteria:

  • Current alcohol withdrawal (AW), evidenced by AW scale > 7
  • Participants who report 50% greater reduction in drinks per day between screening and randomization
  • Severe psychiatric conditions, including past or current DSM5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or current suicidality
  • DSM5 diagnosis of current moderate or severe substance use disorder for a substance other than alcohol or nicotine
  • Traumatic brain injury involving current concussive symptoms or a Post-Concussion Syndrome score greater than or equal to 12
  • Urine drug screen positive for cannabis use
  • Exposure to trauma in the last 30 days, including police duty or military service
  • Significant laboratory abnormalities, including significantly impaired hepatic function*, abnormalities in complete blood count or metabolic panel
  • Current use of exclusionary medications, including those acting on serotonergic pathways, antipsychotics, anticonvulsants, and psychostimulants, treatments for addictions including alcohol, and medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7
  • Pregnancy or lactation.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Duna Abu-amara, MPH 646 754 4793 Duna.Abu-amara@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03248167
Other Study ID Numbers  ICMJE 17-00949
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Charles Marmar, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP