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

South West Sydney Local Health District

Status and phase: Enrolling; Phase 2

Conditions: Alcohol Use Disorder (AUD)

Treatments: Drug: Placebo; Drug: Cannabidiol (CBD)

Study type: Interventional

Funder types: Other

Identifiers

NCT05387148

X19-0416

Details and patient eligibility

About

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

Full 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. 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Cannabidiol (CBD)

Experimental group

Description:

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

Treatment:

Drug: Cannabidiol (CBD)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo