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LSD Clinical Trials

LSD Treatment for Persons With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo Controlled Phase II Study

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Id: NCT05474989

Organisation Name: University Hospital, Basel, Switzerland

Overal Status: Not yet recruiting

Start Date: January 1, 2023

Last Update: July 26, 2022

Lead Sponsor: Felix Mueller

Brief Summary: Alcohol use causes more overall harm than any other drug and is the seventh leading risk factor for both deaths and disability-adjusted life years. Alcohol use disorders (AUD) are among the most common and undertreated mental disorders in developed countries. Pharmacological and psychotherapeutic treatments only show limited efficacy and around 60% of the patients relapse in short-term after withdrawal.

Lysergic acid diethylamide (LSD) was extensively investigated in the 1950s and 1960s and became one of the best-studied psychoactive substances with several thousands of early scientific reports. 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 and the improvements surpassed treatment with established psychopharmacological interventions. However, these historical studies do not meet today's methodological standards which limits the validity of these findings. Well-designed studies are needed to further investigate this promising treatment approach.

Therefore, the present study aims to evaluate safety and efficacy of LSD for the treatment of AUD. The trial has a double-blind, active placebo-controlled, randomized, parallel design and will be conducted in three specialized treatment centers for addictive disorders in Switzerland. The study will include 128 patients after withdrawal treatment and will primarily assess the efficacy of LSD for relapse prevention after standard detoxification. Patients will be treated using a 1:1 allocation. In the first session, patients in the treatment group will receive a dose of 150 µg LSD, followed by another 150 µg or 250 µg LSD in the second session, which will take place approximately 4 weeks after the first session.

The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD at 3 months' follow-up. Additionally, other alcohol associated parameters and associated common comorbidities as well as potential predictors and mediators for treatment response will be assessed.

  • Alcohol Use Disorder (AUD)

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