Acute dose-dependent effects of dimethyltryptamine (DMT) bolus applications in healthy subjects
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Basel
(BASEC)
Sponsor
Prof. Dr. med. Matthias Liechti
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Matthias Liechti
+41 61 328 68 68
matthias.liechti@clutterusb.chClinical Pharmacology & Toxicology, University Hospital Basel
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
20.09.2022
(BASEC)
ICTRP Studien-ID
NCT05695495 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Acute dose-dependent effects of DMT-bolus applications in healthy subjects (BASEC)
Wissenschaftlicher Titel
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study). (ICTRP)
Öffentlicher Titel
Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study) (ICTRP)
Untersuchte Krankheit(en)
Healthy (ICTRP)
Untersuchte Intervention
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)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
14.11.2022 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Matthias E Liechti, Prof.Dr.med., matthias.liechti@usb.ch, +41 61 268 68 68 (ICTRP)
Sekundäre IDs
BASEC 2022-01224 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05695495 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar