Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

NCT ID: NCT04205682

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cannabidiol (CBD)

Drug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD).

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5

Placebo

Drug: Placebo (days 1-5: placebo matched BD)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsules administered BD for 5 days

Interventions

Cannabidiol

CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5

Intervention Type: DRUG

Placebo

Placebo capsules administered BD for 5 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged 18-65 years;
• At least one prior episode 2 days or longer in duration during which the participant experienced withdrawal symptoms that caused significant incapacitation (e.g. inability to work or do normal activities) OR at least one prior inpatient or outpatient medical detoxification during which the participant exhibited withdrawal symptoms of significant magnitude that sedative-hypnotic or anticonvulsant medication was required at least once on 2 consecutive days after cessation of or reduction in the use of alcohol following 2 weeks or more of heavy daily consumption;
• Average consumption of at least 8 standard drinks per day for at least 2 weeks prior to enrolment in the study;
• Adequate cognition and English language skills to give valid consent and complete research interviews;
• Willingness to give written informed consent

Exclusion Criteria

• Treatment/ingestion during the previous week of benzodiazepines or other sedative-hypnotic medications or history of recent chronic treatment with sedative-hypnotic medication as evidenced by a negative urine drug screen at baseline
• History of alcohol withdrawal related seizures
• Substance use in the previous week, defined as > 3 times per week (not including nicotine or caffeine), inclusive of non-prescribed pharmaceuticals (ATOP to be collected at screening)
• Active major psychiatric disorder associated with psychosis, or significant suicide risk (e.g. Bipolar, Schizophrenia)
• Pregnancy or lactation - Women shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed where necessary
• History of confirmed seizures during adulthood, and/or current use of anti-epileptic drugs (AED)
• Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)
• Serious medical illness impacting on safety/participation, defined as an unstable medical state in the opinion of the trial medical officer
• Low body weight (body mass index < 17)
• Severe cognitive impairment or insufficient English or literacy to complete study processes
• Concurrent use of drugs potentially exacerbated by CBD via CYP3A5

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sydney

OTHER

Sponsor Role: collaborator

South Eastern Sydney Local Health District

OTHER_GOV

Sponsor Role: collaborator

South West Sydney Local Health District

OTHER

Sponsor Role: lead

Responsible Party

Professor Paul Haber

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Haber, MBBS

Role: PRINCIPAL_INVESTIGATOR

Sydney Local Health District

Nicholas Lintzeris, MBBS

Role: PRINCIPAL_INVESTIGATOR

South Eastern Sydney Local Health District

Iain McGregor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Kirsten Morley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sydney

Locations

Sydney and Sydney Eye Hospital

Sydney, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Countries

Australia

Central Contacts

Kirsten Morley, PhD

Role: CONTACT

kirsten.morley@sydney.edu.au

+61295153636

Facility Contacts

Nicholas Lintzeris, MBBS

Role: primary

nicholas.lintzeris@health.nsw.gov.au

Kirsten Morley, PhD

Role: primary

kirsten.morley@sydney.edu.au

+61295153636

Other Identifiers

X18-0163

Identifier Type: -

Identifier Source: org_study_id