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LSD Treatment for Persons With Alcohol Use Disorder (LYSTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05474989
Recruitment Status : Not yet recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Collaborators:
University of Bern
University Hospital, Geneva
Information provided by (Responsible Party):
Felix Mueller, University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE July 20, 2022
First Posted Date  ICMJE July 26, 2022
Last Update Posted Date July 26, 2022
Estimated Study Start Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2022)
Percent heavy drinking days [ Time Frame: Period of three months after the second intervention ]
The primary outcome is the mean of percent heavy drinking days after administration of two doses of LSD assessed with the alcohol timeline follow-back (TLFB) questionnaire compared between treatment groups
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2022)
  • Percent heavy drinking days [ Time Frame: Period of one month after the first administration ]
    Percent heavy drinking days after the first administration assessed with TLFB
  • Days to first heavy drinking day [ Time Frame: Period of one month after the first administration and and three months after the second intervention ]
    Days to first heavy drinking day after first and second administration assessed with TLFB
  • Days to first drinking day [ Time Frame: Period of one month after the first administration and and three months after the second intervention ]
    Days to first drinking day assessed after first and second administration assessed with TLFB
  • Percent days abstinent [ Time Frame: Period of one month after the first administration and and three months after the second intervention ]
    Percent days abstinent after first and second administration assessed with TLFB
  • Drinks per drinking day [ Time Frame: Period of one month after the first administration and and three months after the second intervention ]
    Drinks per drinking day after first and second administration assessed with TLF
  • Craving [ Time Frame: One month after the first administration and and three months after the second intervention ]
    Craving assessed with Obsessive Compulsive Drinking Scale
  • Carbohydrate-deficient transferrin [ Time Frame: One month after the first administration and and three months after the second intervention ]
    Carbohydrate-deficient transferrin (CDT) in blood
  • General health [ Time Frame: One month after the first administration and and three months after the second intervention ]
    General health assessed with General Health Questionnaire
  • Adverse consequences of alcohol use [ Time Frame: Three months after the second intervention ]
    Adverse consequences of alcohol use assessed with Short Inventory of Problems
  • Impulsivity [ Time Frame: Three months after the second intervention ]
    Impulsivity assessed with the Barratt impulsiveness Scale
  • Depression [ Time Frame: Three months after the second intervention ]
    Depression assessed with Inventory of Depressive Symptomatology - self rated
  • Anxiety [ Time Frame: Three months after the second intervention ]
    Anxiety assessed with Spielberger state-trait anxiety inventory
  • Persisting effects [ Time Frame: Three months after the second intervention ]
    Persisting effects of LSD administration assessed with Persisting Effects Questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LSD Treatment for Persons With Alcohol Use Disorder
Official Title  ICMJE LSD Treatment for Persons With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo Controlled Phase II Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder (AUD)
Intervention  ICMJE
  • Drug: LSD
    Moderate to high dose LSD
  • Drug: Active placebo
    Low dose LSD
Study Arms  ICMJE
  • Experimental: Verum
    Subjects in the treatment arm will receive 150 μg LSD (first session) and 150 or 250 μg LSD (second session).
    Intervention: Drug: LSD
  • Active Comparator: Active placebo
    Subjects in the control arm will receive 10 µg LSD at the first session and 10 µg LSD at the second session.
    Intervention: Drug: Active placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 24, 2022)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Age ≥ 25 years
  • Participants must meet the DSM-V criteria for a moderate to severe alcohol use disorder and want to stop or decrease their drinking
  • Participants must have underwent an alcohol detoxification within the 30 days prior to screening
  • Participants must have been abstinent since withdrawal treatment
  • Participants must have had at least 20% heavy drinking days (HDD) in the 90 days prior to their alcohol detoxification.
  • Patients must be willing to discontinue medications (e.g. most antidepressants and antipsychotics) in cases where drug related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life [typically 3-7

Exclusion criteria:

  • Moderate to severe cognitive impairment
  • Past or present diagnosis of a DSM-V psychotic or bipolar disorder in subjects or first-degree relatives
  • Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to LSD with high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g. borderline personality disorder)
  • Suicide risk or very likely to require psychiatric hospitalization during the course of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Felix Müller, PD Dr. med. +41 (0)61 325 5111 felix.mueller@upk.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05474989
Other Study ID Numbers  ICMJE 2022-00121
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Felix Mueller, University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Felix Mueller
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Bern
  • University Hospital, Geneva
Investigators  ICMJE Not Provided
PRS Account University Hospital, Basel, Switzerland
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP