The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

NCT04205682

Alcohol Withdrawal Alcohol Dependence

UNKNOWN EARLY_PHASE1

CBD for the Treatment of Alcohol Use Disorder

NCT04873453

Alcohol Use Disorder

COMPLETED PHASE2

Cannabidiol for Alcohol Use Disorder

NCT03904849

Alcohol Use Disorder

WITHDRAWN PHASE1/PHASE2

Alcohol Use Disorder and Cannabidiol

NCT05613608

Alcohol Use Disorder

RECRUITING PHASE2/PHASE3

Effects of Cannabidiol in Alcohol Use Disorder

NCT03252756

Alcohol Use Disorder

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. Cannabidiol (CBD) may serve as a novel pharmacotherapeutic due to its anxiolytic, anti-epileptic, neuro-protective, antioxidant and neuroprotective properties as well as a particularly safe side effect profile. Further, CBD has been shown to modulate drug craving and seeking behaviours.

This project will examine whether CBD exerts an effect on cue-induced craving by reducing activation in areas of the brain responsive to alcohol cues in comparison to a placebo. This study will use functional magnetic resonance imaging (fMRI) to examine activity in the brain while participants are exposed alcohol related cues and magnetic resonance spectroscopy (MRS) to determine levels of neurotransmitters that may be responsible for craving. In addition, we aim to investigate the effects of CBD on autonomic nervous system parameters associated with alcohol withdrawal symptoms and anxiety, such as heart rate variability and skin conductance. Additionally, clinical outcome measures will be taken to investigate CBDs influence on drinking, sleep

This project uses a randomised, double blind, crossover design with 800mg CBD vs matched placebo. The dosing paradigm will consist of one dose per day for three days per arm with a 18 days washout period in-between arms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder (AUD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cannabidiol (CBD)

For a total of three days, so that both study participants and staff are blind to treatment condition

Group Type EXPERIMENTAL

Cannabidiol (CBD)

Intervention Type DRUG

Four 200mg soft gel capsules of Cannabidiol (CBD) will be taken orally daily for a total of 3 days.

Placebo

For a total of three days, so that both study participants and staff are blind to treatment condition

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo will be identical in appearance, taste, and composition except for the active ingredient of pure CBD. So, four 200mg soft gel capsules of the placebo will be taken orally daily for a total of 3 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabidiol (CBD)

Four 200mg soft gel capsules of Cannabidiol (CBD) will be taken orally daily for a total of 3 days.

Intervention Type DRUG

Placebo

The placebo will be identical in appearance, taste, and composition except for the active ingredient of pure CBD. So, four 200mg soft gel capsules of the placebo will be taken orally daily for a total of 3 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female patients between ages of 18 and 65 meeting DSM-5 criteria for current alcohol use disorder
* Adequate cognition and English language skills to give valid consent and complete research interviews;
* A BrAC reading of 0.00
* Must have a stable residence and be able to identify an individual who could locate subject if needed
* Provision of informed consent

Exclusion Criteria

* Active major psychological disorder associated with psychosis, significant suicide risk
* 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;
* Dependence on any substance other than nicotine (eg methadone)
* Diagnosis of epilepsy, and/or current use of anti-epileptic drugs (AED)
* Liver failure with jaundice or prolonged INR above 1.3
* Medical complications such as liver failure, cardiac ischemia or conduction abnormalities, renal impairment or unstable elevated vital signs (systolic blood pressure \> 180, diastolic blood pressure \> 120 or heart rate \> 150)
* Severe cognitive impairment or insufficient English or literacy to complete study processes
* Concurrent use of drugs potentially exacerbated by CBD via CYP3A5 including cardiac medication (e.g. betablockers, calcium channel blockers and statins), macrolides and recent antihistamine use.
* Claustrophobia;
* Extreme obesity;
* Previous brain surgery;
* Ever employed as a machinist, a welder or a metal worker;
* Metal items such as pacemakers; aneurysm clips in the brain; metal dental implants; metallic fragments in the eye or anywhere else; insulin pump; metal implants; hearing aid or a prosthetic device.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No