Effects of Cannabidiol in Alcohol Use Disorder

NCT03252756 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 17-01001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Cannabidiol; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (13)

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Baseline

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Week 1

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Week 4

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Week 5

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Week 8

• Trough CBD Plasma Levels

  CBD "trough" plasma levels measured before dosing with CBD.

  Week 9

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Baseline

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Day 1

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Week 1

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Week 4

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Week 4 + 1 Day

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Week 5

• Peak CBD Plasma Levels

  CBD "peak" plasma levels measured 45 minutes after dosing with CBD.

  Week 8

Secondary Outcomes (38)

• Percentage of Heavy Drinking Days

  Baseline

• Percent of Heavy Drinking Days

  Week 1

• Percent of Heavy Drinking Days

  Week 2

• Percent of Heavy Drinking Days

  Week 3

• Percent of Heavy Drinking Days

  Week 4

Study Arms (2)

Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks

EXPERIMENTAL

600mg/day Saline taken by mouth (PO) for 4 weeks, immediately followed by 1200mg saline/ day (PO) for an additional 4 weeks (8 total weeks).

Other: Placebo

CBD for 8 weeks

EXPERIMENTAL

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)

Interventions

Placebo OTHER

Saline taken by mouth (PO)

Placebo for 4 weeks, followed by phytocannabinoid cannabidiol (CBD) for 4 weeks

Phytocannabinoid cannabidiol (CBD) DRUG

CBD taken by mouth (PO)

CBD for 8 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current alcohol withdrawal (CIWA-Ar score \>7)
• 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
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator
• Tilray: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Michael Bogenschutz, PhD
• Organization: NYU Langone Health

Michael.Bogenschutz@nyulangone.org

646-501-4026

Study Officials

• Michael Bogenschutz, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized proof-of-concept study

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 17, 2017
• Study Start: September 1, 2019
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: May 3, 2023
• Results First Posted: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)