A study on the safety and effects of the drug DMT... — Clinical Trial Details

Participants

Ages

21 – 60

Sexes

Male & Female

BMI

18 - 30

Psychosis History

Excluded

Inclusion Criteria

1. Healthy male and female volunteers.
2. Aged 21 - 60 years inclusive.
3. Regular use of nicotine (at least 1 cigarette daily; 5 to 10 cigarettes daily).
4. Self-report of at least one prior hallucinogen drug experience that included a meaningful altered state of consciousness in the past 5 years (psilocybin, LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs, and/or ketamine).
5. BMI between 18.0 and 30.0 kg/m² inclusive.
6. Healthy based on physical exam, medical history, vitals, and 12-lead ECG (minor ECG abnormalities acceptable if judged not clinically significant).
7. Healthy based on clinical laboratory tests at screening (investigator may include minor non-clinically significant abnormalities documented in source).
8. Agree to refrain from psychoactive drugs, including alcohol, within 24 hours of each drug administration.
9. Signed informed consent.
10. Women of childbearing potential agree to effective contraception during participation up to and including the 90-day follow-up after last DMT dose.
11. Agree to refrain from psychoactive drugs from 30 days before dosing until last follow-up and to refrain from alcohol within 24 hours of dosing.

Exclusion Criteria

1. History of or current liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances deemed clinically significant by the investigator.
2. Clinically relevant abnormal history, physical finding, 12-lead ECG (e.g., PQ/PR >210 ms, LBBB, 2nd-degree or higher AV block), permanent pacemaker/ICD, or lab value at screening that could interfere with objectives or safety.
3. History of or current hypertension (systolic >140 mmHg or diastolic >90 mmHg).
4. Presence or history of cardiovascular disease (acute coronary syndrome, angina, ischemic disease, ventricular arrhythmias, cardiac transplantation).
5. History of chronic or frequent migraines.
6. History of hepatitis B surface antigen or hepatitis C antibody positive, or other clinically active liver disease.
7. HIV antibody positive or tests positive for HIV at screening.
8. Ophthalmologic or neurologic condition that would adversely affect eye movement assessments.
9. History of hypersensitivity or allergic reactions to inactive ingredients in active or placebo products, including compounds related to DMT.
10. Females of childbearing potential with positive urine pregnancy at screening or day of first treatment.
11. Drinks on average more than 8 cups of caffeinated beverages per day.
12. Received an investigational intervention or invasive investigational device within 90 days (or 5 half-lives) before planned first dose or currently enrolled in another investigational study.
13. History of drug or alcohol use disorder (DSM-IV/DSM-5) within past five years.
14. Positive test result(s) for alcohol and/or drugs of abuse at screening or admission.
15. Current or history of any clinically relevant psychiatric disorder per DSM-IV/DSM-5 (e.g., psychotic disorder, bipolar I/II, personality disorder, major depressive disorder, OCD, panic disorder, anorexia nervosa, bulimia nervosa, GAD, PTSD, ASD).
16. Family history of a relevant psychiatric disorder in first-degree relatives.
17. Persistent psychological effects following previous use of hallucinogens (e.g., anxiety, depressed mood, paranoid ideation, HPPD, recurrent flashbacks).
18. Risk of suicide, as judged by an Investigator, based on available source information (including the C-SSRS) indicating current suicidal ideation or history of active suicidal ideation or suicide attempts.
19. Donated/received blood or blood loss >500 mL within 3 months before screening.
20. Vulnerable subjects (e.g., persons detained or under guardianship).
21. Subject is an employee of the investigator or study site with direct study involvement, or family members thereof.
22. Unable to read/understand consent forms or complete study procedures.

Company

Product

Legal

A study on the safety and effects of the drug DMT in healthy smoking individuals

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

DMT infusion

Interventions

Placebo (saline)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details