LSD - Treatment for Patients with Alcohol Dependence
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Alcohol dependence
(BASEC)
- Existing alcohol dependence - Alcohol withdrawal within the last 30 days and abstinent since - Over 25 years old (BASEC)
Criteri di esclusione
- History of psychotic or bipolar disorder - History of borderline disorder - Psychotic or bipolar disorder in first-degree relatives (BASEC)
Luogo dello studio
Basilea, Berna
(BASEC)
Sponsor
PD Dr. med. Felix Müller, MD Department of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Felix Müller
+41 61 325 5111
felix.mueller@clutterupk.chDepartment of Psychiatry Wilhelm Klein-Strasse 27 CH-4012 Basel
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
06.02.2025
(BASEC)
ID di studio ICTRP
NCT05474989 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
LSD Treatment for Persons With Alcohol Use Disorder (ICTRP)
Malattie studiate
Alcohol Use Disorder (AUD) (ICTRP)
Intervento studiato
Drug: LSDDrug: Active placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Bern (ICTRP)
Contatti aggiuntivi
Felix Mller, PD Dr. med., felix.mueller@upk.ch, +41 (0)61 325 5111 (ICTRP)
ID secondari
2024-02125 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05474989 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile