Alcohol Use DisorderPhase 2PAP-AUDNCT05995769
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
A Phase 2 study testing Psilocybin in people with Alcohol Use Disorder and Alcoholism, run by University of Calgary at 1 site in Canada.
Trial summary
The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Alcoholism
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-5 AUD criteria of at least moderate severity
- Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
- Desire to decrease alcohol consumption
- Limited lifetime hallucinogen use
Who cannot join
- Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
- Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
- Active suicidal ideation or serious attempt within past 3 years
- Currently pregnant, nursing, or trying to become pregnant
- Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
About this study
Official title: Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).
Read the detailed description
The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.
A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing
- Conditions
- Alcohol Use Disorder, Alcoholism
- Being tested
- Psilocybin
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called magic mushrooms, PEX010
Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing
| Study group | Role | What they receive |
|---|---|---|
| High Dose (25mg) | Experimental | PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions Receives: Drug: Psilocybin |
| Low dose (1mg) | Active comparator | PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heavy drinking
Percent heavy drinking days (TLFB)
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Secondary outcomes (10)
Abstinence
Days abstinent (TLFB)
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Biomarkers of alcohol consumption
Phosphatidylethanol (Peth)
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Alcohol cue reactivity
Alcohol urge questionnaire (AUQ)
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Cognitive flexibility
Berg Card Sorting Task
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Depression
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Anxiety
The General Anxiety Disorder 7 (GAD-7) scale
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Quality of life
The World Health Organization Quality of Life (WHOQOL) scale
Measured: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Glutamate levels
MR spectroscopy of glutamate levels in the anterior cingulate cortex
Measured: Change from baseline to 1-week post-dosing
GABA levels
MR spectroscopy of GABA levels in the anterior cingulate cortex
Measured: Change from baseline to 1-week post-dosing
Resting state functional connectivity
Measured: Change from baseline to 1-week post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start20 Mar 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, University of Maryland, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Leah Mayo, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995769
- Sponsor's protocol ID
- REB23-0666
- Acronym
- PAP-AUD
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05995769
- Acronym / sponsor ID
- PAP-AUD / REB23-0666
- Conditions
- Alcohol Use Disorder, Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Johns Hopkins University, University of Maryland, Canadian Institutes of Health Research (CIHR)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 16 Aug 2023 (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 aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).
Detailed description
The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.
A total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing
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 |
|---|---|---|
| High Dose (25mg) | Experimental | Drug: PsilocybinPEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions |
| Low dose (1mg) | Active comparator | Drug: PsilocybinPEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets DSM-5 AUD criteria of at least moderate severity
- Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days
- Desire to decrease alcohol consumption
- Limited lifetime hallucinogen use
Key exclusion criteria (5 listed)
- Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months
- Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis
- Active suicidal ideation or serious attempt within past 3 years
- Currently pregnant, nursing, or trying to become pregnant
- Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test
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 |
|---|---|---|
| PsilocybinAlso: magic mushrooms, PEX010Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing | Drug | High Dose (25mg), Low dose (1mg) |
Primary outcome
Heavy drinking
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Percent heavy drinking days (TLFB)
10 secondary outcomes
Abstinence
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Biomarkers of alcohol consumption
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Alcohol cue reactivity
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Cognitive flexibility
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Depression
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Anxiety
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Quality of life
Time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing
Glutamate levels
Time frame: Change from baseline to 1-week post-dosing
GABA levels
Time frame: Change from baseline to 1-week post-dosing
Resting state functional connectivity
Time frame: Change from baseline to 1-week post-dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- 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.
Leah Mayo, PhD principal investigator
University of Calgary
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 Psilocybin in people with Alcohol Use Disorder and Alcoholism, run by University of Calgary at 1 site in Canada.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 May 2024. 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 Canada. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin O'Grady (587-893-0257, pactlab@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heavy drinking (time frame: Change from baseline to 1-, 4-, and 12-weeks post-dosing). 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 7 May 2024.