Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy (PAP_OXT)

May 13, 2025 updated by: Tatiana Aboulafia Brakha

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from consecutive patients in the Addiction Department who have received approval from the Federal office of Public healthfor compassionate treatment with LSD as part of Psychedelic assisted psychotherapy for refractory anxiety disorder or depression. ol. Main criteria: Inclusion:

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary oxytocin
Time Frame: the day of treatment administration (one day)
oxytocin sampled in the saliva
the day of treatment administration (one day)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
over 6 months
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
over 6 months
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
The 1 day of treatment administration
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
The 1 day of treatment administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatiana Aboulafia Brakha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Actual)

December 11, 2024

Study Completion (Actual)

December 11, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-01122

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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