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.
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.
Australia1 site, 1 recruiting
- 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
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.
- Conditions
- Alcohol Use Disorder (AUD)
- 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 group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) | Experimental | For a total of three days, so that both study participants and staff are blind to treatment condition Receives: Drug: Cannabidiol (CBD) |
| Placebo | Placebo comparator | For 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.
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
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
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
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
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
Absence of any Heavy Drinking Day
Measured by Timeline Follow Back
Measured: Up to 43 days
Mean Alcohol Consumption per Drinking Day
Measured by Timeline Follow Back
Measured: Up to 43 days
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Decision Making
To assess an individual's decision making skills measured through the Columbia Card Task (CCT).
Measured: Up to 43 days
Response Inhibition
To assess an individual's ability to inhibit prepotent responses measured through the Stroop task.
Measured: Up to 43 days
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
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
Markers of neuroinflammation
As measured by differences in blood sampling levels of glutathione.
Measured: Up to 43 days
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.
- First posted24 May 2022
- Study startJun 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, Lambert Initiative for Cannabinoid Therapeutics
- Responsible party
- Principal investigator, Kirsten Morley BPsych MPH PhD, University of Sydney
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Neurobehavioural Mechanism of Cannabidiol (CBD) for Alcohol Dependence: An Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT05387148
- Acronym / sponsor ID
- X19-0416
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Alcohol Withdrawal, Alcohol-Related Disorders, Substance-Related Disorders, Mental Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- University of Sydney, Lambert Initiative for Cannabinoid Therapeutics
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will explore the psychophysiological and neurobiological and mechanisms of CBD in participants with alcohol use disorder
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) | Experimental | Drug: Cannabidiol (CBD)For a total of three days, so that both study participants and staff are blind to treatment condition |
| Placebo | Placebo comparator | Drug: PlaceboFor a total of three days, so that both study participants and staff are blind to treatment condition |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabidiol (CBD)Four 200mg soft gel capsules of Cannabidiol (CBD) will be taken orally daily for a total of 3 days. | Drug | Cannabidiol (CBD) |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
Changes in High Frequency Heart Rate Variability
Time frame: 22 days
To assess whether acute ingestion of CBD can modulate heart rate variability when responding to alcohol cues compared to neutral cues
Changes in Skin Conductance Levels
Time frame: 22 days
To assess whether acute ingestion of CBD modulates skin conductance levels when responding to alcohol cues compared to neutral cues
Changes in Brain Activation
Time frame: 22 days
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
Changes in Neurotransmitter levels in the Brain
Time frame: 22 days
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)
Heavy Drinking Days
Time frame: Up to 43 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.
Absence of any Heavy Drinking Day
Time frame: Up to 43 days
Measured by Timeline Follow Back
Mean Alcohol Consumption per Drinking Day
Time frame: Up to 43 days
Measured by Timeline Follow Back
Alcohol Dependence Severity
Time frame: Baseline
Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence.
Alcohol Craving
Time frame: Up to 43 days
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.
27 secondary outcomes
Changes in Alcohol Craving
Time frame: 22 days
Changes in Alcohol Craving in response to alcohol cues
Time frame: 22 days
Changes in Positive and Negative Mood States
Time frame: 22 days
Changes in Anxiety
Time frame: Up to 43 days
Changes in Depression
Time frame: Up to 43 days
Changes in Stress
Time frame: Up to 43 days
Sleep Disturbances
Time frame: Up to 43 days
Sleep Disturbances
Time frame: 22 days
Changes in Tension Reduction Alcohol Expectancies
Time frame: Up to 43 days
Lifetime Consequences related to Drinking
Time frame: Baseline
Recent Consequences related to Drinking
Time frame: Baseline
Behavioural Inhibition/Avoidance Scales
Time frame: 22 days
Obsessive Compulsive Drinking
Time frame: 22 days
Self-Confidence to Remain Abstinent
Time frame: 22 days
Intolerance of Uncertainty
Time frame: 22 days
Impulsivity
Time frame: 22 days
Alcohol Withdrawal
Time frame: 22 days
Approach and Avoidance towards Alcohol
Time frame: Up to 43 days
Response Time and Visuospatial Skills
Time frame: Up to 43 days
Set-shifting Flexibility, Attention, and Inhibition
Time frame: Up to 43 days
Risk/Reward Taking Behaviour
Time frame: Up to 43 days
Decision Making
Time frame: Up to 43 days
Response Inhibition
Time frame: Up to 43 days
Working Memory Capacity to Update Information
Time frame: Up to 43 days
Working Memory Capacity to Shift Information
Time frame: Up to 43 days
Markers of neuroinflammation
Time frame: Up to 43 days
Markers of Stress
Time frame: Up to 43 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Derived from this study: PubMed 39252861Hurzeler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.