Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04205682
Study type	Interventional
Source	South West Sydney Local Health District
Contact	Kirsten Morley, PhD
Phone	+61295153636
Email	kirsten.morley@sydney.edu.au
Status	Not yet recruiting
Phase	Early Phase 1
Start date	January 2020
Completion date	January 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02901041` - Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism	Phase 3
Completed	`NCT03340051` - Remote Alcohol Monitoring and Episodic Thinking	N/A
Not yet recruiting	`NCT06444243` - Psilocybin-assisted Therapy for Alcohol Use Disorder	Phase 2
Completed	`NCT02705898` - Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women	N/A
Completed	`NCT02486900` - Neurofeedback & Alcohol Dependence	N/A
Completed	`NCT02197598` - Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use	Phase 4
Completed	`NCT02179749` - Mifepristone Treatment of Alcohol Use Disorder	Phase 2
Recruiting	`NCT02385643` - The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients	N/A
Completed	`NCT01828866` - Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients	N/A
Terminated	`NCT01408641` - Topiramate for Alcohol Use in Posttraumatic Stress Disorder	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT01342549` - Treatment Strategy for Alcohol Use Disorders in Veterans With TBI	Phase 3
Completed	`NCT02193204` - Chronic Alcohol, Stress Inflammatory Response and Relapse Risk	N/A
Completed	`NCT01165541` - A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency	Phase 2
Completed	`NCT01176591` - HBPL Study of the Impact of the NK1 Antagonist Aprepitant	Phase 2
Completed	`NCT01056484` - Mindfulness Meditation for Health	Phase 2
Completed	`NCT00585780` - Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse	Phase 1/Phase 2
Completed	`NCT00607620` - Disseminating Organizational SBI Services at Trauma Centers	N/A
Completed	`NCT00884884` - Aripiprazole and Topiramate on Free-Choice Alcohol Use	Phase 2/Phase 3
Completed	`NCT00463346` - Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism	Phase 3