HealthyPhase 1DHTPNCT05829603
Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects
A Phase 1 study testing Dimethyltryptamin (DMT) & Harmine in people with Healthy, run by Reconnect Labs at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dimethyltryptamin (DMT) & Harmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2023to 17 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Single-blind, Randomized, Two-arm, Dose-response Study of DMT and Harmine in Healthy Subjects
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability.
Read the detailed description
Participants will undergo a series of six study days with varying doses of DMT and Harmine. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 24 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.
- Conditions
- Healthy
- Being tested
- Dimethyltryptamin (DMT) & Harmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyltryptamin (DMT) & HarmineDrug
Also called RE01
Six varying doses of a fixed-combination formulation of Dimethyltryptamin (DMT) and harmine
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Six varying doses of a fixed-combination of Dimethyltryptamin (DMT) and harmine Receives: Drug: Dimethyltryptamin (DMT) & Harmine |
| Sequence B | Experimental | Six varying doses of a fixed-combination of Dimethyltryptamin (DMT) and harmine Receives: Drug: Dimethyltryptamin (DMT) & Harmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter "Cmax"
Dose-dependent changes in Cmax of several doses of combined DMT \& Harmine
Measured: Changes from baseline to study days 1,2,3,4,5,6
Pharmacokinetic parameter "Area under the curve (AUC)"
Dose-dependent changes in AUC of several doses of combined DMT \& Harmine
Measured: Changes from baseline to study days 1,2,3,4,5,6
Pharmacokinetic parameter "T1/2"
Dose-dependent changes in T1/2 of several doses of combined DMT \& Harmine
Measured: Changes from baseline to study days 1,2,3,4,5,6
Incidence of Treatment-Emergent Adverse Events
Dose-dependent changes in incidence of adverse drug reactions
Measured: On study days 1,2,3,4,5,6
Blood count (Lab biochemistry)
Changes from baseline in blood count
Measured: Changes from baseline to End of Study, an average of 6 weeks
Clinical chemistry (Lab biochemistry)
Changes from baseline in any clinical chemistry parameter with potential clinical relevance.
Measured: Changes from baseline to End of Study, an average of 6 weeks
Blood coagulation (Lab biochemistry)
Changes from baseline in blood coagulation
Measured: Changes from baseline to End of Study, an average of 6 weeks
QT interval (12-lead Electrocardiogram [ECG])
Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
Measured: Changes from baseline to study days 1,2,3,4,5,6
Blood pressure
Dose-dependent changes in systolic and diastolic blood pressure
Measured: Changes from baseline to study days 1,2,3,4,5,6
Heart rate
Dose-dependent changes in heart-rate
Measured: Changes from baseline to study days 1,2,3,4,5,6
Temperature
Dose-dependent changes in body temperature (in °C)
Measured: Changes from baseline to study days 1,2,3,4,5,6
Genotyping
Collection of saliva-samples to determine genetic polymorphisms
Measured: At screening
Subjective effects
Dose-dependent changes in trajectories of subjective effects
Measured: Changes from baseline to study days 1,2,3,4,5,6
Secondary outcomes (5)
Aliveness - Behavioral Task
Validated instrument developed to assess dose-dependent changes in perceived aliveness.
Measured: Changes from baseline to study days 1,2,3
Heart-rate-Variability, Physical Activity, Sleep Patterns
Wearable device for continuous sensor assessments
Measured: Continuously throughout the study until End of Study, an average of 6 weeks
Heart-rate-variability
Occurence of dose-dependent changes in heart-rate-variability assessed by a wearable device
Measured: Continuously throughout the study until End of Study, an average of 6 weeks
Physical Activity
Occurence of dose-dependent changes in physical activity assessed by a wearable device
Measured: Continuously throughout the study until End of Study, an average of 6 weeks
Sleep Patterns
Occurence of dose-dependent changes in sleep patterns assessed by a wearable device
Measured: Continuously throughout the study until End of Study, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start5 May 2023
- Primary completion17 Sep 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participants will be randomized into one of two sequences. Each sequence consists of six study days with a minimum of 1 day between each study day. The differences between the sequences are a) the order of dosages administered to minimize confounding effects through expectancy and b) a study day containing only one of the two active ingredients, thus covering each combination in a factorial, cross-over design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reconnect Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erich Seifritz, Prof, Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829603
- Sponsor's protocol ID
- DMT-HAR-TOM-P
- Acronym
- DHTP
- Status last verified
- Nov 2023
- First submitted
- 3 Mar 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan available to date.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomized, Two-arm, Dose-response Study of DMT and Harmine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05829603
- Acronym / sponsor ID
- DHTP / DMT-HAR-TOM-P
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Reconnect LabsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2023 (actual)
- Primary completion
- 17 Sep 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability.
Detailed description
Participants will undergo a series of six study days with varying doses of DMT and Harmine. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 24 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each participants will be randomized into one of two sequences. Each sequence consists of six study days with a minimum of 1 day between each study day. The differences between the sequences are a) the order of dosages administered to minimize confounding effects through expectancy and b) a study day containing only one of the two active ingredients, thus covering each combination in a factorial, cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: Dimethyltryptamin (DMT) & HarmineSix varying doses of a fixed-combination of Dimethyltryptamin (DMT) and harmine |
| Sequence B | Experimental | Drug: Dimethyltryptamin (DMT) & HarmineSix varying doses of a fixed-combination of Dimethyltryptamin (DMT) and harmine |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyltryptamin (DMT) & HarmineAlso: RE01Six varying doses of a fixed-combination formulation of Dimethyltryptamin (DMT) and harmine | Drug | Sequence A, Sequence B |
Primary outcome
Pharmacokinetic parameter "Cmax"
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in Cmax of several doses of combined DMT \& Harmine
Pharmacokinetic parameter "Area under the curve (AUC)"
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in AUC of several doses of combined DMT \& Harmine
Pharmacokinetic parameter "T1/2"
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in T1/2 of several doses of combined DMT \& Harmine
Incidence of Treatment-Emergent Adverse Events
Time frame: On study days 1,2,3,4,5,6
Dose-dependent changes in incidence of adverse drug reactions
Blood count (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 6 weeks
Changes from baseline in blood count
Clinical chemistry (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 6 weeks
Changes from baseline in any clinical chemistry parameter with potential clinical relevance.
Blood coagulation (Lab biochemistry)
Time frame: Changes from baseline to End of Study, an average of 6 weeks
Changes from baseline in blood coagulation
QT interval (12-lead Electrocardiogram [ECG])
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes of QT intervals assessed by clinical 12-lead ECG)
Blood pressure
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in systolic and diastolic blood pressure
Heart rate
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in heart-rate
Temperature
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in body temperature (in °C)
Genotyping
Time frame: At screening
Collection of saliva-samples to determine genetic polymorphisms
Subjective effects
Time frame: Changes from baseline to study days 1,2,3,4,5,6
Dose-dependent changes in trajectories of subjective effects
5 secondary outcomes
Aliveness - Behavioral Task
Time frame: Changes from baseline to study days 1,2,3
Heart-rate-Variability, Physical Activity, Sleep Patterns
Time frame: Continuously throughout the study until End of Study, an average of 6 weeks
Heart-rate-variability
Time frame: Continuously throughout the study until End of Study, an average of 6 weeks
Physical Activity
Time frame: Continuously throughout the study until End of Study, an average of 6 weeks
Sleep Patterns
Time frame: Continuously throughout the study until End of Study, an average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No. No plan available to date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erich Seifritz, Prof principal investigator
Psychiatric University Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimethyltryptamin (DMT) & Harmine in people with Healthy, run by Reconnect Labs at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameter "Cmax" (time frame: Changes from baseline to study days 1,2,3,4,5,6). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.