AzTrials
AzTrials

Alcohol WithdrawalEarly Phase 1NCT04205682

Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

A Early Phase 1 study testing Cannabidiol in people with Alcohol Withdrawal and Alcohol Dependence, run by South West Sydney Local Health District at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Alcohol Withdrawal, Alcohol Dependence
What is being tested?
Cannabidiol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
2 sitesAustralia
Study dates
Jan 2020to Jan 2021
Phase
Early Phase 1
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

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

Kirsten Morley, PhD contact

+61295153636

kirsten.morley@sydney.edu.au

Australia2 sites

  • Sydney and Sydney Eye Hospital

    Sydney, New South Wales, 2000

    Nicholas Lintzeris, MBBS, nicholas.lintzeris@health.nsw.gov.au

    Nicholas Lintzeris, MBBS

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

    Kirsten Morley, PhD, +61295153636, kirsten.morley@sydney.edu.au

    Paul Haber, MBBS

Other trials in Australia

About this study

Official title: A Randomised Controlled Trial of Cannabidiol (CBD) for the Treatment of Alcohol Withdrawal

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.

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. 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.

Being tested
Cannabidiol, Placebo
Medical subject headings
Alcoholism

What participants receive

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

  • CannabidiolDrug

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

  • PlaceboDrug

    Placebo capsules administered BD for 5 days

Study groups in NCT04205682
Study groupRoleWhat they receive
Cannabidiol (CBD)ExperimentalDrug: Cannabidiol (day 1: 1200 mg (800 mg BD); day 2-4: 800 mg (400 mg BD); day 5: placebo BD).
Receives: Drug: Cannabidiol
PlaceboPlacebo comparatorDrug: Placebo (days 1-5: placebo matched BD)
Receives: Drug: Placebo

What is being measured

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

  1. Diazepam

    Diazepam use over the 5-day withdrawal period (which due to symptom triggered regimen is a proxy measure for withdrawal severity). Measured by total diazepam use over 5 day period.

    Measured: 5 day admission period

Secondary outcomes (14)

  1. Alcohol Withdrawal Severity

    Measured by Alcohol Withdrawal Scale (AWS), minimum score is 0, maximum score is 27 where higher scores indicate greater withdrawal severity.

    Measured: 5 day admission period

  2. Self-reported Alcohol Withdrawal Severity

    As measured by the Alcohol Withdrawal Severity Checklist (AWSC), a self-report measure of withdrawal severity, minimum score is 0, maximum score is 64 where higher scores indicate greater self-reported withdrawal severity.

    Measured: 5 day admission period (twice daily)

  3. Self-reported alcohol craving

    As measured by the Penn Alcohol Craving Scale (PACS), minimum score is 0, maximum score is 30 where higher scores indicate greater alcohol craving

    Measured: Baseline, Day 5, and Day 12 and 33 Follow Up

  4. Self-reported urges to drink

    As measured by the Alcohol Urge Questionnaire (AUQ), minimum score is 8, maximum score is 56, where higher scores indicate greater urges to drink

    Measured: Twice Daily, days 1-5

  5. Actiwatch for sleep quality

    as measured using data obtained from the actiwatch worn by participants for duration of inpatient stay

    Measured: 5 day admission period

  6. Self-reported sleep quality

    as measured using the Insomnia Severity Index (ISI), minimum score is 0, maximum score is 28, where higher scores indicate greater insomnia severity.

    Measured: Baseline, Day 5, and Follow Up (Day 12, Day 33)

  7. Subjective measure of patient satisfaction

    Measured using the Treatment Satisfaction Questionnaire for Medication (TSQM), minimum score is 13, maximum score is 80, where higher scores indicate greater treatment satisfaction.

    Measured: Day 5 and follow up (day 12 and 33)

  8. Liver function tests for clinical markers of liver injury

    as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood

    Measured: Baseline and follow up (day 12 and 33).

  9. Plasma levels of benzodiazepines

    As measured by concentration of benzodiazepines in blood plasma

    Measured: Daily (days 1-5)

  10. Plasma levels of cannabidiol

    As measured by concentration of cannabidiol in blood plasma

    Measured: Daily (days 1-5)

  11. Mood

    Depression, Anxiety and Stress Symptoms measured by the Depression, Anxiety and Stress Scale (DASS-21), minimum score is 0, maximum score is 63, where higher scores indicate greater levels of depression, anxiety and stress.

    Measured: Baseline, day 5 and follow up day 12 and 33.

  12. Cognitive Functioning

    As measured by the Montreal Cognitive Assessment (MoCA), maximum score is 30 and where higher scores indicate greater cognitive functioning.

    Measured: Baseline, day 5 and follow up day 12 and 33.

  13. Cognitive Functioning

    Executive functioning measured by time taken to complete the Trail Making Test A and B (in seconds), where lower scores indicate greater functioning.

    Measured: Baseline, day 5 and follow up day 12 and 33.

  14. Comorbid Anxiety Disorders

    Assessed using the MINI Neuropsychiatric Interview indicating the presence or absence of anxiety disorders

    Measured: 4 week follow up (day 33)

Timeline

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

  1. First posted19 Dec 2019
  2. Study startJan 2020 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJan 2021 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04205682
Sponsor's protocol ID
X18-0163
Status last verified
Jan 2020
First submitted
5 Nov 2019
Last updated
9 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cannabidiol in people with Alcohol Withdrawal and Alcohol Dependence, run by South West Sydney Local Health District at 2 sites 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 11 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Diazepam (time frame: 5 day admission period). 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 NCT04205682.

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 9 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in