LSD - Treatment for Patients with Alcohol Dependence
Summary description of the study
Hallucinogens (substances that cause changes in thinking and perception, e.g., LSD) may potentially improve the symptoms of alcohol dependence. This study investigates the efficacy of a medium to high dose of lysergic acid diethylamide (LSD) compared to a low dose of LSD (active placebo) as treatment for patients with alcohol dependence. The focus is particularly on the risk of relapse after alcohol withdrawal. Participants are randomly assigned to the high-dose group or the low-dose group (placebo). The high-dose group receives 150 µg of LSD in the first substance session and 150 µg or 250 µg of LSD in the second substance session. The placebo group receives 10 µg in the first substance session and also 10 or 20 µg in the second substance session. In addition to efficacy in alcohol dependence, microstructural changes in the brain are also examined over the course of the study using MRI. Furthermore, group treatments are compared with individual treatments.
(BASEC)
Intervention under investigation
We compare the effect of a repeated administration of a medium to high dose of LSD with a repeated administration of a low dose of LSD (active placebo)
(BASEC)
Disease under investigation
Alcohol dependence
(BASEC)
- Existing alcohol dependence - Alcohol withdrawal within the last 30 days and abstinent since - Over 25 years old (BASEC)
Exclusion criteria
- History of psychotic or bipolar disorder - History of borderline disorder - Psychotic or bipolar disorder in first-degree relatives (BASEC)
Trial sites
Basel, Bern
(BASEC)
Sponsor
PD Dr. med. Felix Müller, MD Department of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Felix Müller
+41 61 325 5111
felix.mueller@clutterupk.chDepartment of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
06.02.2025
(BASEC)
ICTRP Trial ID
NCT05474989 (ICTRP)
Official title (approved by ethics committee)
Investigating efficacy and microstructural plasticity of LSD treatment in patients with alcohol use disorder: A multicenter, double-blind, randomized, active-placebo controlled phase II neuroimaging study (BASEC)
Academic title
LSD Treatment for Persons With Alcohol Use Disorder: A Multicenter, Double-blind, Randomized, Active-placebo Controlled Phase II Study (ICTRP)
Public title
LSD Treatment for Persons With Alcohol Use Disorder (ICTRP)
Disease under investigation
Alcohol Use Disorder (AUD) (ICTRP)
Intervention under investigation
Drug: LSD;Drug: Active placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 25 Years
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
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
(ICTRP)
not available
Primary and secondary end points
Percent heavy drinking days (ICTRP)
Cortical thickness measured with MRI;The volume of the striatum measured with MRI;White matter microstructure measured with MRI;Days to first heavy drinking day;Days to first drinking day;Percent days abstinent;Drinks per drinking day;Adverse consequences of alcohol use;Craving;Ethyl glucuronide;Phosphatidylethanol;General health;Depression;Anxiety;Blinding;Safety: Adverse events (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Bern (ICTRP)
Additional contacts
Felix M?ller, PD Dr. med., felix.mueller@upk.ch, +41 (0)61 325 5111 (ICTRP)
Secondary trial IDs
2022-00121 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05474989 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available