ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Cannabidiol in Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03252756
Recruitment Status : Not yet recruiting
First Posted : August 17, 2017
Last Update Posted : May 25, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Other: Placebo Drug: Phytocannabinoid cannabidiol (CBD) Phase 1 Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized proof-of-concept study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Cannabidiol in Alcohol Use Disorder
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Placebo Comparator: Placebo
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
Other: Placebo
600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).

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).
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).




Primary Outcome Measures :
  1. Change in Time-line Follow-back (TLFB) assessment of alcohol consumption in Serum [ Time Frame: Baseline to 4 weeks ]
  2. Change in Percent carbohydrate deficient transferrin (CDT) assessment of alcohol consumption in Serum [ Time Frame: Baseline to 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-5 diagnosis of moderate or severe AUD
  • able to provide voluntary informed consent
  • at least 10 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a man) in the 30 days prior to screen
  • not currently in treatment for AUD

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,
  • Current suicidality
  • DSM-5 diagnosis of current moderate or severe substance use disorder for a -substance other than alcohol or nicotin
  • marijuana or other cannabinoid use within 30 days prior to screen
  • 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 those acting on serotonergic pathways, antipsychotics, anticonvulsants, and psychostimulants, treatments for addictions including alcohol, and medications metabolized primarily by CYP3A4, CYP3A5, or CYP3A7

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252756


Contacts
Contact: Tara Malone 646-501-4026 tara.malone@nyumc.org
Contact: Michael Bogenschutz 646-501-4026

Locations
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
National Institutes of Health (NIH)
Investigators
Principal Investigator: Michael Bogenschutz, PhD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03252756     History of Changes
Other Study ID Numbers: 17-01001
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

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

Keywords provided by New York University School of Medicine:
Cannabidiol
Alcohol Use Disorder

Additional relevant MeSH terms:
Disease
Alcohol Drinking
Pathologic Processes
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs