LSD - Treatment for Patients with Alcohol Dependence
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Alcohol dependence
(BASEC)
- Existing alcohol dependence - Alcohol withdrawal within the last 30 days and abstinent since - Over 25 years old (BASEC)
Ausschlusskriterien
- History of psychotic or bipolar disorder - History of borderline disorder - Psychotic or bipolar disorder in first-degree relatives (BASEC)
Studienstandort
Basel, Bern
(BASEC)
Sponsor
PD Dr. med. Felix Müller, MD Department of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. med. Felix Müller
+41 61 325 5111
felix.mueller@clutterupk.chDepartment of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.02.2025
(BASEC)
ICTRP Studien-ID
NCT05474989 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
Investigating the 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. (ICTRP)
Öffentlicher Titel
LSD Treatment for Persons With Alcohol Use Disorder (ICTRP)
Untersuchte Krankheit(en)
Alcohol Use Disorder (AUD) (ICTRP)
Untersuchte Intervention
Drug: LSDDrug: Active placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Key inclusion criteria:
- Age = 25 years
- Participants must meet the DSM-5 criteria for a moderate to severe alcohol use
disorder and must intend to stop or decrease their drinking for at least the
duration of the study
- Participants must have underwent an alcohol detoxification within the 60 days prior
to screening or, in cases where no detoxification is necessary, must have been
abstinent for at least 14 days.
- A minimum of 4 HDD within the last 30 days before detoxification or cessation of
alcohol use (a HDD is defined as 5 or more standard drinks per day for a man and 4
drinks for a woman a standard drink is defined as 12 g of alcohol)
Key exclusion criteria:
- Significant alcohol withdrawal symptoms at screening
- Participating or starting in any formal treatment for AUD from visit 1 until
completion of the double-blind phase
- Treatment with disulfiram during the study
- Past or present diagnosis of a DSM-5 psychotic or bipolar disorder in subjects or
first-degree relatives
- Current suicidality or history of a serious suicide attempt (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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;Percent heavy drinking days;Adverse consequences of alcohol use;Craving;Ethyl glucuronide;Phosphatidylethanol;Perceived quality of life across multiple domains;Depression;Anxiety;Various somatic and psychological symptoms;World view;Persisting effects;Mindfulness;Acute effects of LSD;Acute effects of LSD;Acute effects of LSD;Acute effects of LSD;Blinding;Expectancy;Self-efficacy;Drinking goals;Safety: Adverse events;Qualitative Interview (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern (ICTRP)
Weitere Kontakte
Felix Mller, PD Dr. med., felix.mueller@upk.ch, +41 (0)61 325 5111 (ICTRP)
Sekundäre IDs
2024-02125 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05474989 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar