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LSD Treatment for Persons With Alcohol Use Disorder

RecruitingPhase 2Ages 25 Years - anyAllFelix Mueller
NCT05474989 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Lysergic acid diethylamide (LSD) was investigated in numerous clinical trials during the 1950s and 1960s. Specifically, the use of LSD in the treatment of AUD was investigated extensively. A pooled analysis of six historical clinical trials demonstrated that a single dose of LSD significantly reduced alcohol use at three and six months after LSD administration. However, these trials are limited by several factors, including the use of diagnostic standards that are no longer up to date, single, high-dose treatment regimes, missing biological assessment for alcohol use, and no consequent assessment of blinding. This trial will assess the efficacy and safety of two moderate to high doses of LSD to decrease alcohol consumption in patients with AUD. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in specialized treatment centers for

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📋 Eligibility rules (as published)
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
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What it tests

  • LSD
  • Active placebo
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Where

2 sites
University Hospital of Psychiatry, University of Basel
Basel, Switzerland
University Hospital of Psychiatry, University of Bern
Bern, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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