Psilocybin therapy for treating alcohol use disorder
The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.
This study is testing if a single high dose of psilocybin, along with support, can help people with alcohol use disorder drink less over 12 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Psychiatric Centre Rigshospitalet Academic / other |
| Locations | 1 site (Frederiksberg) |
| Trial ID | NCT05416229 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of a single high dose of psilocybin combined with psychological support for patients diagnosed with alcohol use disorder (AUD). It is a randomized, double-blinded, placebo-controlled study involving 90 participants aged 20-70 years, who will be assessed over 12 weeks for changes in heavy drinking days and other biomarkers. The study will also explore the neurobiological effects of psilocybin using functional MRI. Participants will be recruited from the community and assessed at multiple time points post-dosing.
Who should consider this trial
Good fit: Ideal candidates are Danish citizens aged 20-70 with a diagnosis of alcohol use disorder and a history of heavy drinking.
Not a fit: Patients with a history of psychotic disorders, severe neurological diseases, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective approach to reducing alcohol dependence in patients.
How similar studies have performed: Other studies have shown promising results with psilocybin in treating various addictions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Bodyweight of 50-110 kg * AUD according to DSM-5 criteria and alcohol dependence according to ICD-10. * AUD Identification Test (AUDIT) ≥ 15. * ≥ 5 heavy drinking days in the past 28 days prior to inclusion. Exclusion Criteria: * Current or previously diagnosed with any psychotic disorder or bipolar affective disorder. * Immediate family member with a diagnosed psychotic disorder. * History of delirium tremens or alcohol withdrawal seizures. * History of suicide attempt or present suicidal ideation at screening. * Withdrawal symptoms at screening (\>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43). * Present or former severe neurological disease including trauma with loss of consciousness \> 30 min. * Impaired hepatic function (alanine transaminase \>210/135 units/l men/women) * Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg). * Present or former abnormal QTc (\>450/470 ms men/women). * Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion. * Treatment with any serotonergic medication or drugs within one month prior inclusion. * Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score \>six/two (men/women) and investigator's clinical evaluation. * Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44). * Unable to speak or understand Danish. * Any other condition that the clinician estimates can interfere with trial participation.
Where this trial is running
Frederiksberg
- Psychiatric Center Copenhagen, Frederiksberg Hospital — Frederiksberg, Denmark (Recruiting)
Study contacts
- Principal investigator: Anders Fink-Jensen, Professor — Psychiatric Center Copenhagen, Frederiksberg Hospital
- Study coordinator: Mathias E Jensen, MD
- Email: mathias.ebbesen.jensen.01@regionh.dk
- Phone: +45 61634663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.