Acute dose-dependent effects of dimethyltryptamine (DMT) bolus applications in healthy subjects
Descrizione riassuntiva dello studio
The study investigates the immediate changes in consciousness during and after the administration of the hallucinogen dimethyltryptamine. A total of 36 healthy subjects will participate in this study. The study will be conducted in accordance with applicable Swiss laws and internationally recognized principles.
(BASEC)
Intervento studiato
The study is divided into two arms. In the randomized arm, you will receive, on the study day, in an unknown order, once a placebo, once 5 mg of DMT, once 10 mg, once 15 mg of DMT, and once 20 mg of DMT intravenously as a bolus, with one hour between each dose. Neither you nor your doctor know when you will receive which DMT dose or placebo ('double-blind'). The order of conditions is randomly determined. Thus, all subjects receive four dosages and one placebo, but in a different order. In the escalating arm, however, the DMT dose is known to both the study doctor and you. You start with an intravenous DMT bolus of 5 mg, which is gradually increased by 5 mg up to a maximum of 25 mg. The administration of the boluses will also occur at one-hour intervals. You continuously and independently decide how many dose increases you would like to receive. Your decision should aim to achieve the best and/or most pleasant effect possible. Once negative effects predominate (for example, 'too strong effect'), you should stop the dose escalation. Your goal should explicitly not be to 'push your limits' or to reach the 'maximum tolerable'. Therefore, you will receive at least one DMT bolus and at most five DMT boluses, depending on how many dose increases you wish to perform. You will be assigned either to the randomized study arm or the dose-escalating study arm. You can choose the study arm you wish to participate in, as long as there is still space available in both study arms.
(BASEC)
Malattie studiate
The study investigates the altered state of consciousness induced by the substance N,N-dimethyltryptamine (DMT). DMT is classified as one of the so-called 'classic' hallucinogens (also: psychedelics), as it acts on a specific serotonin receptor (5-HT2A receptor) similar to LSD, psilocybin, and mescaline. This receptor is invoked as an explanation for the effects of hallucinogenic substances. This study examines how the stimulation of the 5-HT2A receptor by different doses of intravenously administered DMT manifests in the body and psyche. A potential therapeutic effect of DMT is not investigated in this study.
(BASEC)
- You are physically and mentally healthy and have no first-degree relatives suffering from psychotic or bipolar disorders. - You are between 25 and 65 years old. - You speak fluent German. (BASEC)
Criteri di esclusione
- You suffer from hypertension. - You have consumed hallucinogenic substances more than 20 times in your life or at any time in the last two months (excluding THC), are a heavy smoker, or drink more than 20 alcoholic beverages per week. - You are simultaneously participating in another clinical study. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
Prof. Dr. med. Matthias Liechti
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Matthias Liechti
+41 61 328 68 68
matthias.liechti@clutterusb.chClinical Pharmacology & Toxicology, University Hospital Basel
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
20.09.2022
(BASEC)
ID di studio ICTRP
NCT05695495 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Acute dose-dependent effects of DMT-bolus applications in healthy subjects (BASEC)
Titolo accademico
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study). (ICTRP)
Titolo pubblico
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (ICTRP)
Malattie studiate
Healthy (ICTRP)
Intervento studiato
Drug: N,N-Dimethyltryptamine (5mg)Drug: N,N-Dimethyltryptamine (10mg)Drug: N,N-Dimethyltryptamine (15mg)Drug: N,N-Dimethyltryptamine (20mg)Drug: N,N-Dimethyltryptamine (25mg)Drug: Placebo (saline) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
1. Age between 25 and 65 years old
2. Sufficient understanding of the German language
3. Understanding of procedures and risks associated with the study
4. Willing to adhere to the protocol and signing of the consent form
5. Willing to refrain from the consumption of illicit psychoactive substances during
the study
6. Abstaining from xanthine-based liquids from the evenings prior to the study sessions
and during the sessions
7. Willing not to operate heavy machinery within 6 h of DMT administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2.
Exclusion Criteria:
1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania /
hypomania, anxiety disorders).
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time
within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (>10 cigarettes/day)
10. Consumption of alcoholic beverages (>20 drinks/week) (ICTRP)
non disponibile
Endpoint primari e secondari
Altered states of consciousness profile (OAV);Subjective effect ratings over time (ICTRP)
Psychedelic experience questionnnaire (PEQ);Near death experience content scale (NDE-C);Spiritual Realms Questionnaire (SRQ);Blood pressure;Heart rate;Plasma level DMT;Urine recovery of DMT;NEO-Five-Factor-Inventory (NEO-FFI);Saarbr�cker Personality Questionnaire (SPF);Elliot Humility Scale (EHS) (ICTRP)
Data di registrazione
14.11.2022 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Matthias E Liechti, Prof.Dr.med., matthias.liechti@usb.ch, +41 61 268 68 68 (ICTRP)
ID secondari
BASEC 2022-01224 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05695495 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile