Clinical TrialHealthy VolunteersDMTDMTCompleted

Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects (DHTP)

Randomised Phase I study (n=16) comparing PK/PD and safety of six varying doses of a fixed-combination of DMT and harmine across six study days in healthy volunteers with continuous psychological support.

Target Enrollment
16 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Randomised allocation to one of two sequences (Sequence A or B). Each participant undergoes six study days with a minimum of one day between days; sequences differ by dose order and by inclusion of study days containing only one active ingredient to cover combination effects in a factorial manner.

Pharmacokinetic and pharmacodynamic assessments are obtained over 24 hours on each study visit to estimate dose–exposure relationships and drug–drug interaction; safety/tolerability is monitored continuously and participants receive psychological support in a controlled environment.

Study Protocol

Preparation

sessions

Dosing

6 sessions
1440 min each

Integration

sessions

Study Arms & Interventions

Sequence A

experimental

Six varying doses of a fixed-combination of DMT and harmine administered across six study days (sequence A).

Interventions

  • DMT
    via Oral• six sessions• 6 doses total

    Fixed-combination DMT + harmine (RE01); six varying doses across study days; harmine co-administered; dosing order per Sequence A.

Sequence B

experimental

Six varying doses of a fixed-combination of DMT and harmine administered across six study days (sequence B).

Interventions

  • DMT
    via Oral• six sessions• 6 doses total

    Fixed-combination DMT + harmine (RE01); six varying doses across study days; harmine co-administered; dosing order per Sequence B.

Participants

Ages
25 – 45
Sexes
Male & Female

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 (oral/injected/implanted hormonal methods, IUD/IUS, or barrier methods with spermicide)

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 addiction 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, myocardial 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
  • Pregnant or breastfeeding women (a urine pregnancy test will be done for all women capable of bearing children)
  • Occurrence of premenstrual dysphoric disorder (PMDD)
  • 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)
  • Optional wearable data collection sub-cohort: possession of a smartphone capable of running the latest version of the TeleWear application and Withings® HealthMate application

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment16 participants
  • Timeline
    Start: 2023-05-01
    End: 2023-08-01
  • Compounds
    DMTDMT
  • Topic
    Healthy Volunteers

Locations

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

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