Salivary Oxytocin as a Biomarker in Psychedelic Assisted Psychotherapy (PAP_OXT)
This observational pilot study (n=10) will examine salivary oxytocin levels during a single dose of LSD as part of psychedelic-assisted psychotherapy (PAP) for anxiety disorders or depression.
Detailed Description
Primary objective is to obtain preliminary data on salivary oxytocin reactivity during a single clinical LSD intake administered as part of PAP for refractory anxiety or depression under compassionate-use authorisation.
No interference with routine clinical care: four saliva samples will be collected on the day of dosing and participants will complete routine self-report questionnaires; participants are selected from consecutive patients in the Addiction Department.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
LSD + PAP
experimentalSingle clinical-dose LSD administered as part of routine psychedelic-assisted psychotherapy with saliva sampling for oxytocin.
Interventions
- LSDvia Oral• single dose• 1 doses total
Single LSD dose given in clinical routine (dose per treating team); four saliva samples collected on dosing day.
Participants
Inclusion Criteria
- Inclusion Criteria:
- Ongoing psychotherapy with a certified psychotherapist
- Anxiety disorder or depression resistant to usual treatments
- Agreement to stop necessary medication
- Adults 18–50 years
Exclusion Criteria
- Exclusion Criteria:
- Psychotic or bipolar disorder
- High suicidal risk
- Severe cardiovascular disease
- Severe liver disease
- Neurological disease of the central nervous system
- Pregnancy and breastfeeding
Study Details
- StatusCompleted
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment10 participants
- TimelineStart: 2024-08-05End: 2424-12-31
- Compound
- Topic