LSD for people with alcohol use disorder

Investigating the Efficacy and Microstructural Plasticity of LSD Treatment in Patients With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo-controlled Phase II Neuroimaging Study.

This study will see if one or two doses of LSD can help adults with moderate to severe alcohol use disorder drink less and stay sober longer compared with an active placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 2 sites (Basel and 1 other locations)
• Trial ID: NCT05474989 on ClinicalTrials.gov

What this trial studies

This is a Phase 2, randomized, double-blind trial comparing LSD to an active placebo in adults with moderate to severe DSM-5 alcohol use disorder who intend to stop or reduce drinking. Participants must be at least 25 years old and recently detoxified or abstinent, and they receive two administrations during the blinded phase with follow-up assessments up to six months; an open-label phase with additional assessments follows. Outcome measures include self-report drinking measures, standardized questionnaires (e.g., TLFB, OCDS, SIP-2R), biological alcohol markers, and adverse event monitoring. The trial updates and extends historical single-dose LSD research by using modern diagnostics, repeated dosing, biological verification of alcohol use, and blinded controls.

Who should consider this trial

Good fit: Adults aged 25 or older with moderate to severe DSM-5 alcohol use disorder who have completed detoxification within 60 days or been abstinent at least 14 days and want to stop or reduce drinking are the intended participants.

Not a fit: People with significant alcohol withdrawal at screening, current or a first-degree relative history of psychotic or bipolar disorder, those starting formal AUD treatment during the blinded phase, or those taking disulfiram are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide a new medication-assisted option that reduces heavy drinking and relapse after detoxification.

How similar studies have performed: Historical trials from the 1950s–60s and a pooled analysis showed a single high dose of LSD reduced alcohol use at three and six months, but those studies used outdated diagnostics and lacked biological measures, so this modern randomized trial builds on promising but limited prior evidence.

Eligibility criteria

Key inclusion criteria:

* Age ≥ 25 years
* Participants must meet the DSM-5 criteria for a moderate to severe alcohol use disorder and must intend to stop or decrease their drinking for at least the duration of the study
* Participants must have underwent an alcohol detoxification within the 60 days prior to screening or, in cases where no detoxification is necessary, must have been abstinent for at least 14 days.
* A minimum of 4 HDD within the last 30 days before detoxification or cessation of alcohol use (a HDD is defined as 5 or more standard drinks per day for a man and 4 drinks for a woman; a standard drink is defined as 12 g of alcohol)

Key exclusion criteria:

* Significant alcohol withdrawal symptoms at screening
* Participating or starting in any formal treatment for AUD from visit 1 until completion of the double-blind phase
* Treatment with disulfiram during the study
* Past or present diagnosis of a DSM-5 psychotic or bipolar disorder in subjects or first-degree relatives
* Current suicidality or history of a serious suicide attempt

Where this trial is running

Basel and 1 other locations

• University Hospital of Psychiatry, University of Basel — Basel, Switzerland (Recruiting)
• University Hospital of Psychiatry, University of Bern — Bern, Switzerland (Recruiting)

Study contacts

• Study coordinator: Felix Müller, PD Dr. med.

Conditions Alcohol Use Disorder