Clinical TrialHealthy VolunteersPlaceboTerminated

Dose-finding PKPD Trial for RE02 in Healthy Subjects

This double-blind, randomized, dose-response trial (n=15) aims to assess the pharmacokinetic and pharmacodynamic profiles of RE02, a psychedelic drug, in healthy subjects.

Target Enrollment
15 participants
Study Type
Phase I interventional
Design
Randomized, triple Blind

Detailed Description

Randomized, triple-masked crossover in healthy volunteers comparing three RE02 dose levels with a mannitol placebo across four single-dose study days, with a 6-hour intensive PK/PD assessment on each day.

Primary aims are dose–exposure characterisation and safety/tolerability; intervention embedded in a controlled setting with continuous psychological support and close adverse-event monitoring.

Study Protocol

Preparation

sessions

Dosing

4 sessions
360 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Placebo

inactive

Placebo comparator (mannitol)

Interventions

  • Placebo
    • single dose• 1 doses total

    Mannitol placebo (placebo comparator)

Low dose RE02

experimental

Low dose of RE02 (single-dose session)

Interventions

  • Compound
    • single dose• 1 doses total

    RE02 — low dose (not specified in registry)

Moderate dose RE02

experimental

Moderate dose of RE02 (single-dose session)

Interventions

  • Compound
    • single dose• 1 doses total

    RE02 — moderate dose (not specified in registry)

High dose RE02

experimental

High dose of RE02 (single-dose session)

Interventions

  • Compound
    • single dose• 1 doses total

    RE02 — high dose (not specified in registry)

Participants

Ages
25 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
  • Willing to refrain from drinking alcohol one day before testing days and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
  • Already experienced with psychedelic substances (at least 5 prior experiences - microdoses do not count)
  • Able and willing to comply with all study requirements
  • Informed consent form was signed
  • Good knowledge of the German language
  • Participant informs study physicians / project scientists about simultaneous treatment or therapy with other physicians and about current intake of psychotropic substances or medication
  • Women of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

Exclusion Criteria

  • Exclusion Criteria:
  • Previous significant adverse response to a hallucinogenic drug
  • Participation in another study where pharmaceutical compounds will be given
  • Presence of Axis I affective, anxiety, or dissociative disorders
  • Present or antecedent diagnosis of bipolar disorder (I, II, not otherwise specified), schizophrenia, schizoaffective disorder, psychosis, or other disorders from the psychotic spectrum
  • First-degree relatives with present or antecedent schizophrenia, schizoaffective disorder, or bipolar disorder type I
  • History of head trauma, seizures, cancer, or cerebrovascular accidents
  • Recent cardiac or brain surgery
  • Current abuse of medication or psychotropic substances (including nicotine addiction) according to SCID I criteria
  • Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
  • Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardical infarction, coronary spastic angina)
  • Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
  • Cerebrovascular disease (e.g., stroke, intracranial bleeding / hemorrhage, intracranial aneurysm)
  • Serious abnormalities in ECG or blood count/chemistry
  • Liver or renal or pulmonary disease
  • Current use of medications with significant interaction potential with MAOI (e.g., antidepressants, antipsychotics, psychostimulants, dopaminergic/serotonergic agents, anticonvulsants)
  • high risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, serious current stressors, lack of social support)

Study Details

  • Status
    Terminated
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment15 participants
  • Timeline
    Start: 2023-11-20
    End: 2024-01-31
  • Compound
    Placebo
  • Topic
    Healthy Volunteers

Locations

University Hospital of Psychiatry Zurich — Zurich, Canton of Zurich, Switzerland

Your Library