Alcohol Use DisorderPhase 2NCT05646303
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
A Phase 2 study testing Psilocybin in people with Alcohol Use Disorder, run by Clairvoyant Therapeutics at 12 sites in 2 countries.
Trial summary
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are: Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? Is treatment… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 2 May 2022to 31 Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
- Expressed a wish to reduce or stop alcohol consumption.
- Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
Who cannot join
- Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
- Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
- History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada8 sites
Sabi Mind
Calgary, Alberta, T3C 0J7
Centricity Research
Halifax, Nova Scotia, B3S 1N2
MacAnxiety Research Centre
Hamilton, Ontario, L8S 1B7
Okanagan Clinical Trials
Kelowna, British Columbia
Department of Psychiatry, Queen's University
Kingston, Ontario
Centre for Neurology Studies
Surrey, British Columbia
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
University of British Columbia, Department of Psychiatry, BRAIN Lab
Vancouver, British Columbia, V6T 1Z3
Finland4 sites
Research Center Oxidi Oy / Addiktum Oy
Helsinki
A-Klinikka
Kouvola, 45100
Mentacare Oy
Oulu
Addiktum Oy
Turku
About this study
Official title: A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are:
- Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
- Is treatment with psilocybin and therapy safe for participants?
Participants will
- Attend 13 study visits
- Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
- Record their daily alcohol consumption on study specific device
Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
- Conditions
- Alcohol Use Disorder
- Being tested
- Psilocybin, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin and psychotherapy
PlaceboDrug
Placebo and psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | 2 oral doses of 25mg psilocybin capsules Receives: Drug: Psilocybin |
| Placebo | Placebo comparator | 2 oral doses of placebo (microcrystalline cellulose) capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of Heavy Drinking Days
Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start2 May 2022
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clairvoyant Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimapharm
- Responsible party
- Sponsor
- Investigators
- Hannu Alho, MD, Principal investigator, Addiktum Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646303
- Sponsor's protocol ID
- CLA PSY 201
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-Week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT05646303
- Acronym / sponsor ID
- CLA PSY 201
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Clairvoyant TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Optimapharm
- Study start
- 2 May 2022 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Dec 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 goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are:
- Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
- Is treatment with psilocybin and therapy safe for participants?
Participants will
- Attend 13 study visits
- Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
- Record their daily alcohol consumption on study specific device
Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin2 oral doses of 25mg psilocybin capsules |
| Placebo | Placebo comparator | Drug: Placebo2 oral doses of placebo (microcrystalline cellulose) capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
- Expressed a wish to reduce or stop alcohol consumption.
- Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
Key exclusion criteria (3 listed)
- Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
- Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
- History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.
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 |
|---|---|---|
| PsilocybinPsilocybin and psychotherapy | Drug | Psilocybin |
| PlaceboPlacebo and psychotherapy | Drug | Placebo |
Primary outcome
Reduction in the number of Heavy Drinking Days
Time frame: 8 weeks
Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or ≥40 g alcohol/day (if female).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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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.
Hannu Alho, MD principal investigator
Addiktum Oy
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Alcohol Use Disorder, run by Clairvoyant Therapeutics at 12 sites in 2 countries.
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 3 inclusion and 3 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 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of Heavy Drinking Days (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.