Clinical TrialAlcohol Use Disorder (AUD)LSDLSDNot yet recruiting

LSD Treatment for Persons With Alcohol Use Disorder (LYSTA)

Double-blind, randomised, active placebo-controlled parallel study (n=126) testing two LSD doses (150 µg; second session 150 or 250 µg) versus low-dose active placebo (10 µg) for alcohol use disorder.

Target Enrollment
126 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This is a randomised, double-blind, active placebo-controlled parallel study in specialised addiction treatment centres in Switzerland evaluating LSD for the treatment of moderate to severe alcohol use disorder.

Participants receive two dosing days (treatment arm: 150 µg then 150 or 250 µg; comparator: 10 µg then 10 µg). The primary outcome is percent heavy drinking days at three months after administration; secondary objectives include neurobiological mechanisms.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

LSD high dose

experimental

Two-dose LSD regimen with possible escalation in second session (150 µg first; second session 150 µg or 250 µg).

Interventions

  • LSD150 - 250 µg
    via Oral• two sessions• 2 doses total

    Second session 150 µg or 250 µg

Low-dose LSD

active comparator

Active placebo arm receiving low-dose LSD (10 µg) in both sessions.

Interventions

  • LSD10 µg
    via Oral• two sessions• 2 doses total

    10 µg active placebo in both sessions

Participants

Ages
25 – 99
Sexes
Male & Female

Inclusion Criteria

  • Key inclusion criteria:
  • age ≥ 25 years
  • moderate to severe AUD
  • completion of a qualified detoxification for AUD within 30 days prior to screening
  • a minimum of 4 heavy drinking days within the last 30 days before detoxification
  • intention to stop or decrease drinking

Exclusion Criteria

  • Key exclusion criteria:
  • significant alcohol withdrawal symptoms at screening
  • participating or starting in any formal treatment for AUD until completion of visit 9
  • cognitive impairment
  • borderline personality disorder
  • current post-traumatic stress disorder
  • current suicidality or history of a serious suicide attempt
  • significant prodromal symptoms
  • history of a diagnosis of a psychotic or bipolar disorder in subjects or first-degree relatives
  • pregnancy or breast-feeding
  • lack of safe contraception are exclusion criterion for women only

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment126 participants
  • Timeline
    Start: 2023-01-01
    End: 2025-01-01
  • Compounds
    LSDLSD
  • Topic
    Alcohol Use Disorder (AUD)

Locations

University Hospital of Psychiatry, University of Basel — Basel, Switzerland
University Hospital of Psychiatry, University of Bern — Bern, Switzerland

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