NCT04205682

Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: South West Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will explore the effectiveness and tolerability of Cannabidiol (CBD) in the treatment of alcohol withdrawal symptoms in an inpatient setting, in a double-blind randomised placebo-controlled trial.

Detailed description

New treatment strategies for treating symptoms of alcohol dependence are urgently needed. Although alcohol related disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence-based. Contemporary treatment for managing alcohol withdrawal in Australia involves administration of benzodiazepines that, while often effective for managing withdrawal symptoms, have concerns regarding their use including: a major abuse liability potential in this population; their sedating effects and potential for adverse events (e.g. falls, overdose, cognitive impairment) if used in combination with other sedatives; and an increased risk of relapse due to symptoms of alcohol dependence that return after cessation of treatment (e.g. increased sleep problems and anxiety). However, no other safe and effective alternatives to benzodiazepines in treating alcohol withdrawal have yet been demonstrated. This project will pilot the clinical efficacy and tolerability of Cannabidiol (CBD) relative to placebo in the treatment of alcohol withdrawal in an inpatient setting across two study sites. This is a double-blind, randomised controlled design. The trial will recruit 52 participants undergoing alcohol withdrawal, using a 1:1 random allocation into one of two treatment groups as follows: (1) CBD (Day 1: 1200 mg/day; Day 2-4: 800 mg/day; Day 5: placebo washout; n = 26), or (2) matched placebo (n = 26). All participants will be administered a symptom triggered diazepam medication regimen, as per conventional best-practice management of alcohol withdrawal.

Conditions

• Alcohol Withdrawal
• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Cannabidiol	CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5
DRUG	Placebo	Placebo capsules administered BD for 5 days

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2019-12-19
• Last updated: 2020-01-09

Locations

2 sites across 1 country: Australia