Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy

NCT ID: NCT06557239

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-05

Study Completion Date

2024-12-11

Brief Summary

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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

Detailed Description

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Conditions

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Depression, Anxiety

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Lysergic Acid Diethylamide (LSD)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tatiana Aboulafia Brakha

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Aboulafia Brakha

Principal Investigator-Head of psychologists

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2024-01122

Identifier Type: -

Identifier Source: org_study_id

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