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Alcohol Use Disorder (AUD)Phase 2NCT05387148

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

A Phase 2 study testing Cannabidiol (CBD) in people with Alcohol Use Disorder (AUD), run by South West Sydney Local Health District at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Use Disorder (AUD)
What is being tested?
Cannabidiol (CBD)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteAustralia
Study dates
Jun 2022to Jun 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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 locations and contacts

1 site in 1 country.

Kirsten Morley, PhD contact

+61295153636

kirsten.morley@sydney.edu.au

Australia1 site, 1 recruiting
  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

    Kirsten Morley, PhD, Kirsten.morley@sydney.edu.au

    Central Contact Line, 0459877108, sydneyalcoholtreatmentgroup@gmail.com

    Recruiting

Other trials in Australia

About this study

Official title: The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence: An Exploratory Pilot Study

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

Read the 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. 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.

Being tested
Cannabidiol (CBD), Placebo
Keywords
Alcohol Withdrawal, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders
Medical subject headings
Alcoholism, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabidiol (CBD)Drug

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

  • PlaceboDrug

    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.

Study groups in NCT05387148
Study groupRoleWhat they receive
Cannabidiol (CBD)ExperimentalFor a total of three days, so that both study participants and staff are blind to treatment condition
Receives: Drug: Cannabidiol (CBD)
PlaceboPlacebo comparatorFor a total of three days, so that both study participants and staff are blind to treatment condition
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in High Frequency Heart Rate Variability

    To assess whether acute ingestion of CBD can modulate heart rate variability when responding to alcohol cues compared to neutral cues

    Measured: 22 days

  2. Changes in Skin Conductance Levels

    To assess whether acute ingestion of CBD modulates skin conductance levels when responding to alcohol cues compared to neutral cues

    Measured: 22 days

  3. Changes in Brain Activation

    To assess whether acute ingestion of CBD can attenuate brain activation via blood oxygen level dependent (BOLD) in areas associated with alcohol cue-elicited craving measured by an fMRI machine

    Measured: 22 days

  4. Changes in Neurotransmitter levels in the Brain

    To assess whether CBD treatment leads to changes in brain levels of the neurotransmitters: glutamate, gamma-aminobutyric acid (GABA), N-acetylaspartate (NAA) and glutathione (GSH)

    Measured: 22 days

  5. Heavy Drinking Days

    Reduction in Heavy Drinking Days (HDD; defined as 4 or more drinks in a day for women and five or more drinks in a day for men). This will be measured by the Timeline Follow Back.

    Measured: Up to 43 days

  6. Absence of any Heavy Drinking Day

    Measured by Timeline Follow Back

    Measured: Up to 43 days

  7. Mean Alcohol Consumption per Drinking Day

    Measured by Timeline Follow Back

    Measured: Up to 43 days

  8. Alcohol Dependence Severity

    Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence.

    Measured: Baseline

  9. Alcohol Craving

    As measured by the Penn Alcohol Craving Scale (PACS), which measures the amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol. This scale has a minimum score of 0 and a maximum score of 6. A higher score indicates greater levels of craving.

    Measured: Up to 43 days

Secondary outcomes (27)
  1. Changes in Alcohol Craving

    To assess whether acute ingestion of CBD can modulate subjective measures of alcohol cue elicited craving. This will be measured during the fMRI scan using the Visual Analogue Scale. This scale will assess alcohol craving, thirst and anxiety.

    Measured: 22 days

  2. Changes in Alcohol Craving in response to alcohol cues

    To assess whether acute ingestion of CBD can modulate subjective measures of alcohol cue elicited craving. This will be measured before and after the fMRI scan using the Alcohol Urge Questionnaire (AUQ). This Questionnaire consists of 8 questions that are scored on a Likert scale of 7 points. Two of the questions are reversed scored. Total score is computed by averaging the item scores. A greater score indicates greater craving.

    Measured: 22 days

  3. Changes in Positive and Negative Mood States

    To assess whether acute ingestion of CBD can modulate subjective measures of positive and negative mood states following alcohol cues. This will be measured before and after the fMRI scan using the Positive and Negative Affect Schedule (PANAS).

    Measured: 22 days

  4. Changes in Anxiety

    Measured by cumulative scores on the DASS-21 Anxiety Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more anxiety.

    Measured: Up to 43 days

  5. Changes in Depression

    Measured by cumulative scores on the DASS-21 Depression Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates greater depression.

    Measured: Up to 43 days

  6. Changes in Stress

    Measured by cumulative scores on the DASS-21 Stress Scale. This scale has a minimum score of 0 and maximum score of 21. A higher score indicates more stress.

    Measured: Up to 43 days

  7. Sleep Disturbances

    As measured by the ISI (Insomnia Severity Index). This Index has a minimum score of 0 and a maximum score of 28. The higher the score indicates more severe insomnia.

    Measured: Up to 43 days

  8. Sleep Disturbances

    To assess whether acute ingestion of CBD has any impact of sleep. This will be measured by an Actiwatch. The Actiwatch records motion and light to determine information about participants sleep and wake patterns. The participants will wear this watch for 48 hours on two separate occasions.

    Measured: 22 days

  9. Changes in Tension Reduction Alcohol Expectancies

    To assess whether CBD treatment can reduce participants need to use alcohol to attenuate tension states (such as anxiety) as measured by the Tension Reduction subscale of the Alcohol Expectancy Questionnaire. Higher scores indicate greater reliance on alcohol to reduce tension/ anxiety.

    Measured: Up to 43 days

  10. Lifetime Consequences related to Drinking

    To examine the adverse consequences a participant has experienced in their lifetime due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Lifetime Edition (DrInC-2L). Higher scores indicate more consequences.

    Measured: Baseline

  11. Recent Consequences related to Drinking

    To examine the adverse consequences a participant has experienced in the last 3 months due to alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. This is measured using the Drinker Inventory of Consequences Recent Edition (DrInC-2R). Higher scores indicate more consequences.

    Measured: Baseline

  12. Behavioural Inhibition/Avoidance Scales

    The BIS/BAS Scale is a 20-item self-report questionnaire designed to measure two motivational systems: the behavioral inhibition system (BIS), which corresponds to motivation to avoid aversive outcomes, and the behavioral activation system (BAS), which corresponds to motivation to approach goal-oriented outcomes.

    Measured: 22 days

  13. Obsessive Compulsive Drinking

    To assess an individuals obsessive thoughts about alcohol use and compulsive behaviours towards drinking as measured by the Obsessive Compulsive Drinking Scale. Six of the questions measure to obsession and eight of the questions measure compulsivity. Higher scores on these subscales indicate more obsession and compulsion, respectively.

    Measured: 22 days

  14. Self-Confidence to Remain Abstinent

    To measure an individual's self-confidence in avoiding alcohol through the Alcohol Abstinence Self-Efficacy Scale (AASE). There are 20 questions and each is scored from 0 to 4. Higher scores on this scale indicate more self-confidence.

    Measured: 22 days

  15. Intolerance of Uncertainty

    To assess an individual's reactions to situations that are ambiguous, the consequences of being uncertain, and attempts the individual might make to control the future. This will be measured through the Intolerance of Uncertainty Scale (IUS). This scale includes 27-items that are scored on a Likert scale (1 - Not at all characteristic of me to 5 - entirely characteristic of me). All scores are summed up and a higher score indicates greater inability to deal with uncertainty.

    Measured: 22 days

  16. Impulsivity

    To assess an individual's impulsivity across four domains: urgency, lack of premeditation and perseverance, and sensation seeking. This will be measured through the Impulsivity Scale (UPPS). Greater scores on this scale indicate greater impulsivity.

    Measured: 22 days

  17. Alcohol Withdrawal

    To assess an individual's severity of alcohol withdrawal through the Clinical Institute Withdrawal Assessment of Alcohol Scale - Revised (CIWA-Ar). Greater scores on this scale indicate the participant is experiencing greater alcohol withdrawal symptoms.

    Measured: 22 days

  18. Approach and Avoidance towards Alcohol

    To assess an individual's automatic action tendencies (either approve or avoid) towards alcohol. This will be measured through the Approach Avoidance Task (AAT).

    Measured: Up to 43 days

  19. Response Time and Visuospatial Skills

    To assess an individual's response time and visuospatial skills through the Trail Making Test Part A (TMT-A).

    Measured: Up to 43 days

  20. Set-shifting Flexibility, Attention, and Inhibition

    To assess an individual's set-shifting flexibility, attention and inhibition through the Trail Making Test Part B (TMT-B).

    Measured: Up to 43 days

  21. Risk/Reward Taking Behaviour

    To assess an individual's risk taking behaviour measured through the Balloon Analogue Risk Task (BART).

    Measured: Up to 43 days

  22. Decision Making

    To assess an individual's decision making skills measured through the Columbia Card Task (CCT).

    Measured: Up to 43 days

  23. Response Inhibition

    To assess an individual's ability to inhibit prepotent responses measured through the Stroop task.

    Measured: Up to 43 days

  24. Working Memory Capacity to Update Information

    To assess an individual's capacity to update working memory information measured through the N-back task.

    Measured: Up to 43 days

  25. Working Memory Capacity to Shift Information

    To assess an individual's capacity to shift between two tasks measured by the Number Letter task.

    Measured: Up to 43 days

  26. Markers of neuroinflammation

    As measured by differences in blood sampling levels of glutathione.

    Measured: Up to 43 days

  27. Markers of Stress

    As measured by differences in blood sampling levels of cortisol. This will be measured at rest, before the fMRI scan and following the fMRI scan.

    Measured: Up to 43 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05387148
Sponsor's protocol ID
X19-0416
Status last verified
May 2022
First submitted
15 May 2022
Last updated
3 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hurzeler TP, Logge W, Watt J, DeMayo MM, Suraev A, McGregor IS, Haber PS, Morley KC. The neurobehavioural effects of cannabidiol in alcohol use disorder: Study protocol for a double-blind, randomised, cross over, placebo-controlled trial. Contemp Clin Trials Commun. 2024 Aug 13;41:101341. doi: 10.1016/j.conctc.2024.101341. eCollection 2024 Oct.

    PubMed 39252861

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol (CBD) in people with Alcohol Use Disorder (AUD), run by South West Sydney Local Health District at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kirsten Morley, PhD (+61295153636, kirsten.morley@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in High Frequency Heart Rate Variability (time frame: 22 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05387148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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