Influence of low doses of LSD on visual perception
Zusammenfassung der Studie
In this study, healthy participants are administered two times a low dose of LSD and one time an inactive substance ("placebo") on three different occasions in random order. Neither the participants nor the experimenter knows the order. After the substance administration, participants will perform computer tasks related to visual perception. Meanwhile, using electrodes attached to the head, electrical brain activity of the participants will be recorded. The study does not aim to evaluate health-related effects of LSD, but to test the effects of LSD on fundamental psychological processes.
(BASEC)
Untersuchte Intervention
D-Lysergsäurediethylamid (0/10/20 mcg)
(BASEC)
Untersuchte Krankheit(en)
Healthy participants
(BASEC)
– ≥18 and ≤65 years old – Body mass index 18-29 – Unimpaired or corrected (glasses/contact lenses) vision (BASEC)
Ausschlusskriterien
– Severe acute or chronic illness – Current or past severe neurological or psychiatric illness (e.g., depression, anxiety disorder, or substance use disorder) – First-degree relative with an existing or past primary psychotic disorder (e.g., schizophrenia, schizoaffective disorder) or bipolar disorder (BASEC)
Studienstandort
Basel
(BASEC)
Sponsor
Prof. Philipp Sterzer, Universitäre Psychiatrische Kliniken Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Lucca Jaeckel, M.Sc.
+41 61 325 8151
Lucca.Jaeckel@clutterupk.chUniversitäre Psychiatrische Kliniken Basel
(BASEC)
Allgemeine Auskünfte
University Psychiatric Clinics Basel,
+41 61 325 81 55;+41 61 325 81 55
Lucca.Jaeckel@clutterupk.ch(ICTRP)
Allgemeine Auskünfte
University Psychiatric Clinics Basel
(ICTRP)
Wissenschaftliche Auskünfte
University Psychiatric Clinics Basel,
+41 61 325 81 55;+41 61 325 81 55
Lucca.Jaeckel@clutterupk.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.06.2023
(BASEC)
ICTRP Studien-ID
NCT05976698 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Effects of LSD on perceptual decision-making in healthy subjects (BASEC)
Wissenschaftlicher Titel
Effects of LSD on Perceptual Decision-making in Healthy Subjects (ICTRP)
Öffentlicher Titel
LSD-Perceptual-Choice-Study (ICTRP)
Untersuchte Krankheit(en)
LSD Reaction (ICTRP)
Untersuchte Intervention
Drug: LSD 10 gDrug: LSD 20 gDrug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Willingness to adhere to the study protocol and sign the consent form
- = 18 and = 65 years of age at Screening
- Body mass index 18-29
- Fluent understanding of German
- Normal or corrected-to-normal vision
- Willingness to not operate a traffic vehicle or heavy machinery 24 hours after
substance administration
- Willingness to refrain from taking illicit psychoactive substances, including
cannabis, for the duration of the study
- Willingness to not consume more than one alcoholic standard drink the night before
the study sessions and not consume alcohol for 24 h after each study session
- Willingness to abstain from xanthine-based liquids from the evenings prior to the
study sessions and during the sessions
- Willingness to use effective birth-control throughout the study duration
- Adequate task performance in the decision-making tasks during a practice session in
the screening visit
Exclusion Criteria:
- Recent (<30 days) or current participation in another clinical trial
- Women that are pregnant, nursing, or planning to become pregnant during the study
period
- Current use of contraindicated/psychoactive medications or illicit drugs
- Lifetime use of classical psychedelics more than 20 times, or any time within the
previous two months
- Consumption of >5 cigarettes per day or >20 alcoholic standard drinks per week
- Severe chronic or acute medical condition
- Hypertension (>140/90 mmHg) or hypotension (<85mmHg systolic)
- Current or lifetime major mental health disorder
- Personal or family (first-degree) history of a primary psychotic disorder (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change in changepoint task;Change in history bias task (ICTRP)
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Basel;University Psychiatric Clinics Basel (ICTRP)
Weitere Kontakte
Philipp Sterzer, Prof. Dr.;Philipp Sterzer, Prof. Dr.;Philipp Sterzer, Prof.Dr., philipp.sterzer@upk.ch, +41 61 325 81 55;+41 61 325 81 55, University Psychiatric Clinics Basel, (ICTRP)
Sekundäre IDs
2023-00763, pk23Sterzer (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05976698 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar