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CompletedPhase 1

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

NCT05829603 · DHTP · Reconnect Labs

Closed to entry
Status
Not accepting participants
Phase 1
Phase
16
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Pharmacokinetic parameter "Cmax"

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Pharmacokinetic parameter "Area under the curve (AUC)"

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Pharmacokinetic parameter "T1/2"

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Incidence of Treatment-Emergent Adverse Events

    Measured over On study days 1,2,3,4,5,6

  • Blood count (Lab biochemistry)

    Measured over Changes from baseline to End of Study, an average of 6 weeks

  • Clinical chemistry (Lab biochemistry)

    Measured over Changes from baseline to End of Study, an average of 6 weeks

  • Blood coagulation (Lab biochemistry)

    Measured over Changes from baseline to End of Study, an average of 6 weeks

  • QT interval (12-lead Electrocardiogram [ECG])

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Blood pressure

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Heart rate

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Temperature

    Measured over Changes from baseline to study days 1,2,3,4,5,6

  • Genotyping

    Measured over At screening

  • Subjective effects

    Measured over Changes from baseline to study days 1,2,3,4,5,6

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 45 Years
Ages
All
Sex
Accepted
Healthy volunteers
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: * 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, 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 * 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 (pilot and main study): Additional inclusion criterion for health data collection sub-cohort using TeleWear and accompanying wearable: possession of a smartphone capable of running the latest version of the TeleWear application and Withings® HealthMate application.

Where

1 study site

FacilityCityRegionCountry
University Hospital of Psychiatry ZurichZurichCanton of ZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05829603 on ClinicalTrials.gov →

Last updated in the registry 2023-11-02. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance