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OpenTrials
Completed

NCT Number: NCT06557239

Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy

The main objective of this pilot study is to obtain preliminary data on the reactivity of salivary oxytocin during a single LSD intake as part of PAP treatment for anxiety disorders or depression (treatment authorisations granted in advance by the Federal Officie of Public Health for compassionate use of the substance).

There will be no interference with the usual clinical routine in our Service. The protocol is only for taking additional saliva measurements to measure oxytocin levels on the day of treatment.

Participants will be asked to give 4 saliva samples the day of their LSD treatment .In addition they will fill-in self-report questionnaires which are part of the clinical routine

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospitals

Geneva, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ongoing psychotherapy with a certified psychotherapist, anxiety disorder or depression resistant to usual treatments, agreement to stop necessary medication

Exclusion criteria

  • Exclusion: psychotic or bipolar disorder, high suicidal risk, severe cardiovascular disease, severe liver disease, neurological disease of the central nervous system, pregnancy and breastfeeding

Treatment and study plan

Lysergic Acid Diethylamide (LSD)

Drug

one single dose of LSD in the context of psychedelic assisted psychotherapy as a part of a clinical routine in our department

Primary outcomes

  1. Salivary oxytocin

    Time frame: the day of treatment administration (one day)

    oxytocin sampled in the saliva

Secondary outcomes

  1. Self-reported symptoms of anxiety (STAI-T)

    Time frame: over 6 months

    State-Trait Anxiety Inventory (trait), total scores ranging from 20 to 80, higher scores indicating higher anxiety

  2. Self-reported depressive symptoms (BDI-II)

    Time frame: over 6 months

    Beck Depresion Inventory-II, total scores ranging from 0 to 63, higher scores indicating higher depressive symptoms

  3. Self-reported intensity of mystical experience

    Time frame: The 1 day of treatment administration

    Assessed with the self-report Mystical experience Questionnaire (MEQ-30) with total man score ranging from 0 to 5, with higher scores indicating higher intensity of mystical experience

  4. Self-reported intensity of Connectedness

    Time frame: The 1 day of treatment administration

    Assessed with the self-report Watts Connectedness Scale,total mean score ranging from 0 to 100, with higher scores indicating higher connectedess

Sponsors and collaborators

Lead sponsor

Tatiana Aboulafia Brakha

Other

Registry information

Official study title

Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy for Anxiety and Depression: a Pilot Study

Acronym: PAP_OXT

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 16, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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