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Psychedelic

5-MeO-DMT for Pharmacokinetics, Safety, and Tolerability

Phase 1
Waitlist Available
Research Sponsored by Usona Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights

Study Summary

This trial studies the effects of an injection of 5-MeO-DMT on healthy people, to see how safe and well-tolerated it is.

Eligible Conditions
  • Pharmacokinetics
  • Safety
  • Tolerability

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v4.0
Secondary outcome measures
Plasma pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT
Urine pharmacokinetic parameters of 5-MeO-DMT and bufotenine following a single-dose and multiple-doses of 5-MeO-DMT

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 9 - multiple-dose, 3 hour intervalExperimental Treatment2 Interventions
Administration of up to two 5-MeO-DMT (2.5 mg followed by 10.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
Group II: Cohort 8 - multiple-dose, 3 hour intervalExperimental Treatment2 Interventions
Administration of up to two 5-MeO-DMT (2.5 mg followed by 7 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
Group III: Cohort 7 - multiple-dose, 3 hour intervalExperimental Treatment2 Interventions
Administration of up to two 5-MeO-DMT (2.5 mg followed by 4.5 mg) or placebo doses administered intramuscularly within a single day with a 3 hour dose interval (randomized as 5 active and 1 placebo subject).
Group IV: Cohort 6 - 13 mg single-doseExperimental Treatment2 Interventions
A single 5-MeO-DMT 13 mg or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Group V: Cohort 5 - 10 mg single-doseExperimental Treatment2 Interventions
A single 10 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Group VI: Cohort 4 - 7 mg single-doseExperimental Treatment2 Interventions
A single 7 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Group VII: Cohort 3 - 4.5 mg single-doseExperimental Treatment2 Interventions
A single 4.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Group VIII: Cohort 2 - 2.5 mg single-doseExperimental Treatment2 Interventions
A single 2.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Group IX: Cohort 1 - 0.5 mg single-doseExperimental Treatment2 Interventions
A single 0.5 mg 5-MeO-DMT or placebo dose administered intramuscularly (randomized as 5 active and 1 placebo subject).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
5-methoxy-N,N-dimethyltryptamine succinate salt
2022
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Usona InstituteLead Sponsor
12 Previous Clinical Trials
704 Total Patients Enrolled
1 Trials studying Pharmacokinetics
60 Patients Enrolled for Pharmacokinetics

Media Library

5-methoxy-N,N-dimethyltryptamine succinate salt (Psychedelic) Clinical Trial Eligibility Overview. Trial Name: NCT05698095 — Phase 1
Pharmacokinetics Research Study Groups: Cohort 1 - 0.5 mg single-dose, Cohort 2 - 2.5 mg single-dose, Cohort 3 - 4.5 mg single-dose, Cohort 4 - 7 mg single-dose, Cohort 5 - 10 mg single-dose, Cohort 6 - 13 mg single-dose, Cohort 7 - multiple-dose, 3 hour interval, Cohort 8 - multiple-dose, 3 hour interval, Cohort 9 - multiple-dose, 3 hour interval
Pharmacokinetics Clinical Trial 2023: 5-methoxy-N,N-dimethyltryptamine succinate salt Highlights & Side Effects. Trial Name: NCT05698095 — Phase 1
5-methoxy-N,N-dimethyltryptamine succinate salt (Psychedelic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05698095 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor inviting individuals who are 60 or older to participate?

"This research project is for people between 18 and 65, but there are separate studies with different age brackets; 4 clinical trials accommodate those below the age of consent while 42 cater to seniors."

Answered by AI

Are participants still being admitted to this experiment?

"Per the information listed on clinicaltrials.gov, this investigation is open to new participants. The trial was first posted December 27th 2022 and has seen a recent update of January 13th 2023."

Answered by AI

How many participants are being recruited for this medical trial?

"Affirmative. Clinicaltrials.gov attests that this research endeavour, which was first advertised on December 27th 2022, is actively searching for participants. A total of 54 individuals are needed to be recruited from a single location."

Answered by AI

Has the FDA granted approval of a 0.5 mg single-dose regimen for Cohort 1?

"As this is a Phase 1 trial, and there is minimal scientific evidence to back up the safety and efficacy of Cohort 1 - 0.5 mg single-dose, it was assigned a score of 1 on our rating scale."

Answered by AI

Am I eligible to take part in this experiment?

"This safety study is open to 54 individuals aged 18 and 65 who are free of any health problems. To be eligible, people must also fit the following criteria: Healthy adult male or female., At least 18 years old but no more than 65 years old, BMI between 18.0 kg/m2 and 32.0 kg/m2 (inclusive)."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
Altasciences Clinical Kansas, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

It's the only one local that I might qualify for.
PatientReceived 2+ prior treatments
~24 spots leftby Mar 2025