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Functional, cognitive and behavioural effects of 5-MeO-DMT administered by intramuscular injection

Effects of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection on frequency oscillatory power bands in healthy adults

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000884606
Enrollment
15
Registered
2023-08-17
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to improve the scientific understanding of the effects of intramuscularly (IM) administered 5-MeO-DMT on human brain activity as well as other indexes of well-being as assessed through psychological, physiological, and biological markers. Finally, we aim to further our understanding of the tolerability and safety profile as well as dose-dependent effects of different doses of 5-MeO-DMT or placebo administered per intramuscular administration and to uncover its phenomenological characteristics.

Interventions

The study employs a single-blind design (only the researchers will know the dosing regimen) involving 15 healthy volunteers. Following successful screening, and after consent is obtained, there will be 4 dosing days, each spaced 2 weeks apart. The four dosing days will involve IM administration of 5-MeO-DMT (3 mg, 6 mg and 9 mg) and inactive placebo. A psychiatrist/medical practitioner will administer the intervention.

Sponsors

Swinburne University of Technology, Hawthorn
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

Physically and mentally healthy. Good command of the English language. Prior experience with a psychedelic without experiencing adverse events. Normal baseline ECG (determined by study medic). Informed consent. No psychedelic use within 2 weeks prior to the experiment. Email access. No anaemia. Normal healthy body mass index (i.e., between 18.5-24.9). Not use caffeine or nicotine 2 hours before or 6 hours after the dose.

Exclusion criteria

Not physically and mentally healthy. No command of the English language. No prior experience with a psychedelic without experiencing adverse events. Abnormal baseline ECG (determined by study medic). No informed consent. Psychedelic use within 2 weeks prior to the experiment. No email access. Anaemia. Abnormal body mass index (i.e., below 18,5 or above 24,9). Not use caffeine or nicotine 2 hours before or 6 hours after the dose.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026