LSD Treatment for Persons With Alcohol Use Disorder
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
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.