A 3-part study to investigate the safety, pharmacodynamics and pharmacokinetics of increasing doses of intravenously administered N,N-dimethyltryptamine (DMT) and deuterated DMT (CYB004) in healthy smokers and non-smokers

Completed

• Conditions: 10027946; Substance use disorders: Tobacco and Nicotine Addiction; nicotine dependence; smoking

• Registration Number: NL-OMON54291
• Lead Sponsor: Cybin IRL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 74

Inclusion Criteria

1. Healthy male and female volunteers.
2. Aged 21 - 60 years inclusive.
3. Part A: Regular use of nicotine (5-10 cigarettes daily).
Part B and C: non-smokers, defined as individuals who have never smoked
tobacco or used nicotine or tobacco containing products, or individuals with no
use of nicotine or tobacco containing products in the past 2 months.
4. Self-report of at least one prior hallucinogen drug experience that included
a meaningful altered state of consciousness (a state in which the subject
experienced phenomena that altered his psychological functioning, such as loss
of ego boundaries, impaired control of actions and cognition, disembodiment,
changed meaning of percepts, visual alterations and audio-visual synesthesia)
the past 5 years. Hallucinogenic substances can include psilocybin, LSD, DMT,
ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE) and/or
ketamine.
5. Participant has a body mass index (BMI) between 18.0 and 30.0 kg/m2
inclusive (BMI=weight/height2).
6. Subject must be healthy based on physical examination, medical history,
vital signs, and 12-lead ECG. Minor abnormalities in ECG, which are not
considered to be of clinical significance by the investigator, are acceptable.
7. Subjects must be healthy based on clinical laboratory tests performed at
screening. If the results of the serum chemistry panel, hematology, or
urinalysis are outside the normal reference ranges, the subject may be included
only if the investigator judges the abnormalities to be not clinically
significant. This determination must be recorded in the subject's source
documents and initialed by the sub investigator.*
8. Agree to refrain from using any psychoactive drugs, including alcoholic
beverages within 24 hours of each drug administration.

Exclusion Criteria

1. Subject has a history of or current liver or renal insufficiency;
significant cardiac, vascular, pulmonary, gastrointestinal, endocrine,
neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances,
any inflammatory illness or any other illness, which are considered to be of
clinical significance by the investigator.
2. Clinically relevant abnormal history, physical finding,12-lead safety
ECG12-lead safety ECG (e.g. PQ/PR interval > 210ms, presence of Left Bundle
Branch Block (LBBB), AV Block (second degree or higher), or a permanent
pacemaker or implantable cardioverter defibrillator [ICD]), or laboratory value
at screening that could interfere with the objectives of the trial or the
safety of the volunteer.
3. Subject has a history of or current hypertension (systolic blood pressure
>140 mmHg or diastolic blood pressure >90 mmHg).
4. Presence or history of cardiovascular disease, including acute coronary
syndrome or angina, ischemic disease, ventricular arrhythmias or cardiac
transplantation as determined by self-report during review of medical history.
5. Subject has a history of chronic or frequent migraines.
6. Females of childbearing potential with positive urine pregnancy at screening
or the day of the first treatment.
7. Subject has a history of drug or alcohol use disorder according to DSM-IV or
DSM 5 within the past five years.
8. Subject has a positive test result(s) for alcohol and/or drugs of abuse
(including: opiates (including methadone), cocaine, amphetamines,
methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening
or admission to the clinical unit.*
9. Current or history of any clinically relevant psychiatric disorder as
classified according to DSM-IV or DSM 5 (e.g. psychotic disorder e.g.
schizophrenia/schizo-affective disorder, bipolar disorder Type I or Type II,
personality disorder, major depressive disorder/persistent depressive disorder,
obsessive-compulsive disorder, panic disorder, anorexia nervosa, bulimia
nervosa, generalized anxiety disorder (GAD), post-traumatic stress disorder
(PTSD) or autism spectrum disorder (ASD).
10. Family history of a relevant psychiatric disorder in first-degree
relatives. Psychiatric history in second degree relatives will be discussed on
a case to case basis.
11. Persistent psychological effects following the previous use of psilocybin,
LSD, DMT, ayahuasca, mescaline, ibogaine, 2C-drugs (such as 2CB, 2CI and 2CE)
and/or ketamine. Such effects might include but are not limited to anxiety,
depressed mood, paranoid ideation and/or hallucinations (including hallucinogen
persisting perception disorder - HPPD) or recurrent flash-backs related to use.
12. Risk of suicide, as judged by an Investigator, based upon available source
information -including the C-SSRS or family history of suicide -indicating
current suicidal ideation or a history of active suicidal ideation or suicide
attempts
13. Positive SARS-CoV-2 rapid antigen test analysis prior to first dosing.

Study & Design

• Study Type: Interventional
• Study Design: Not specified