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Effects of Cannabidiol in Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT03252756
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE August 14, 2017
First Posted Date  ICMJE August 17, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • Change in Time-line Follow-back (TLFB) assessment of alcohol consumption in Serum [ Time Frame: Baseline to 4 weeks ]
  • Change in Percent carbohydrate deficient transferrin (CDT) assessment of alcohol consumption in Serum [ Time Frame: Baseline to 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cannabidiol in Alcohol Use Disorder
Official Title  ICMJE Effects of Cannabidiol in Alcohol Use Disorder
Brief 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). 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, randomized proof-of-concept study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Other: Placebo
    600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
  • Drug: Phytocannabinoid cannabidiol (CBD)
    600mg CBD (PO) for 4 weeks, immediately followed by 1200mg CBD/ day (PO) for an additional 4 weeks (8 total weeks).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
    Intervention: Other: Placebo
  • Experimental: 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).
    Intervention: Drug: Phytocannabinoid cannabidiol (CBD)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

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 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)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lindsay Rosenthal 646-501-9684 lindsay.rosenthal@nyulangone.org
Contact: Michael Bogenschutz, PhD 646-501-4026
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03252756
Other Study ID Numbers  ICMJE 17-01001
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.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal with have access to the data. To gain access, data requestors will need to sign a data access agreement.
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Michael Bogenschutz, PhD NYU Langone Health
PRS Account NYU Langone Health
Verification Date February 2020

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