Using psilocybin with therapy to help reduce heavy drinking in people with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a single dose of psilocybin combined with motivational enhancement therapy (MET) in reducing heavy drinking among individuals diagnosed with alcohol use disorder (AUD). Participants will be randomly assigned to receive either a high dose of psilocybin or a low dose as a control, followed by five sessions of MET. The study will assess changes in heavy drinking days over a 12-week period using the Time Line Follow Back method. A total of 128 participants aged 22-65 will be recruited, and various clinical and neuroimaging measures will be taken to evaluate outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Leah Mayo, PhD — University of Calgary
• Study coordinator: Kaitlin O'Grady
• Email: pactlab@ucalgary.ca
• Phone: 587-893-0257

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for adults with alcohol use disorder

  This study will test whether BrainsWay Deep TMS can reduce heavy drinking in adults with moderate to severe alcohol use disorder compared with a sham procedure.

  Recruiting at 9 sites Brainsway · Tuscaloosa, Alabama and 10 other locations · NCT07216872

• Tirzepatide's effects on alcohol intake in patients with schizophrenia and alcohol use disorder

  This study is testing if the medication tirzepatide can help people with schizophrenia and alcohol use disorder drink less alcohol over six months.

  Recruiting at 2 sites Phase 2 Psychiatric Centre Rigshospitalet · Aalborg, Denmark and 1 other locations · NCT06939088

• Referral to alcohol treatment for patients with liver disease

  This study tests whether sending newly diagnosed patients with alcohol-related liver disease to specialized treatment can help them stop drinking better than just regular care alone.

  Recruiting Zealand University Hospital · Køge, Køge · NCT06493773

• Functional connectivity–guided transcranial magnetic stimulation for alcohol use disorder

  This study will test whether a single fMRI-guided session of transcranial magnetic stimulation (TMS) can reduce alcohol-cue brain reactivity and help people with moderate-to-severe alcohol use disorder stay abstinent.

  Recruiting VA Palo Alto Health Care System · Palo Alto, California · NCT06415721

• Evaluating liver disease screening for individuals with alcohol use disorder

  This study tests if screening for liver disease with a special measurement helps people in alcohol treatment stay sober or drink less over six months.

  Recruiting at 2 sites Zealand University Hospital · Køge and 1 other locations · NCT05855031

• Naltrexone treatment for heavy drinkers with Alcohol Use Disorder

  This study is testing if a long-acting injection of naltrexone can help heavy drinkers cut back on their alcohol use.

  Recruiting Phase 4 University of Pennsylvania · Philadelphia, Pennsylvania · NCT05028062

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.