Clinical trial NCT05695495: Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)
Official title: Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the randomized arm, subjects will be administered intravenous DMT in 4 different bolus doses (5, 10, 15, 20mg) or placebo in randomized, counter-balanced order. In the dose escalation arm, subjects will be administered a placebo and a maximum of 5 DMT bolus doses (5, 10, 15, 20, 25mg) in an escalating dose order. In both arms, the bolus applications will be separated by one hour.
Primary purpose: BASIC_SCIENCE

Brief summary: N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

Detailed description: N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.

Eligibility criteria: 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)

Primary outcomes:
measure: Altered states of consciousness profile (OAV)
timeFrame: Repeatedly 1 hour after each bolus application
measure: Subjective effect ratings over time
timeFrame: Repeatedly 1 hour after each bolus application
Secondary outcomes:
measure: Psychedelic experience questionnnaire (PEQ)
timeFrame: Repeatedly 1 hour after each bolus application
measure: Near death experience content scale (NDE-C)
timeFrame: Repeatedly 1 hour after each bolus application
measure: Spiritual Realms Questionnaire (SRQ)
timeFrame: Once at the end of study day
measure: Blood pressure
timeFrame: Repeatedly in short intervals (2-10 minutes) after each bolus application
measure: Heart rate
timeFrame: Repeatedly in short intervals (2-10 minutes) after each bolus application
measure: Plasma level DMT
timeFrame: Repeatedly in short intervals (2-10 minutes) after each bolus application
measure: Urine recovery of DMT
timeFrame: Once at the end of study day
measure: NEO-Five-Factor-Inventory (NEO-FFI)
timeFrame: Baseline
measure: Saarbrücker Personality Questionnaire (SPF)
timeFrame: Baseline
measure: Elliot Humility Scale (EHS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinical Pharmacology & Toxicology, University Hospital Basel
Study officials:
References: