Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05674669
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female subject aged 21 to 65 years inclusive.
2. For Part 1, subject has been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, on more than 3 occasions during their lifetime. For Part 2, Subject has not been previously exposed to LSD or any other classic psychedelic drug, including psilocybin, mescaline, and ayahuasca, during the past 7 years.
3. Subject was able and willing to give written informed consent, adhere to the compliance terms during participation in the study, undergo the examinations and testing set forth in the clinical study protocol, and clearly and reliably communicate their subjective experiences to the investigator.
4. Female participants of childbearing potential and male participants whose partner was of childbearing potential must have been willing to ensure that they or their partner used effective contraception during the study and for 3 months after the final study drug administration.
Exclusion Criteria:
A. General Health
1. Subject had a presence or clinically relevant history of any psychiatric, respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
2. Subject had a resting blood pressure exceeding 140 mmHg (systolic) or 90 mmHg (diastolic), averaged across 4 assessments taken at least 1 minute apart on the same day.
3. Subject had a presence or relevant history of organic brain disorders (e.g., intracranial hypertension, aneurisms, impaired consciousness, lethargy, or brain tumour).
4. Subject had a relevant history of atopy, hypersensitivity, skin allergies, or allergic reactions to drugs.
5. Subject had a clinical laboratory test result outside the reference ranges of the testing laboratory and considered clinically significant by the investigator.
6. Subject was positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency (HIV) virus I or II at screening.
7. Subject was a current smoker (i.e., had smoked within 1 month prior to the screening visit).
8. Subject had a medical history that would affect the subject's safety or the study endpoints.
9. Subject had used prescription drugs which might potentially interact with the pharmacokinetics of LSD or therapy within 14 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
10. Subject had used over the counter (OTC) medication or therapy, including megadose vitamin therapy (but excluding routine vitamins) within 7 days of first dosing, unless agreed as not clinically relevant by the PI and the Medical Monitor.
11. Subject had donated or received any blood or blood products within the previous 3 months prior to first dosing.
12. Subject could not use a computer to complete simple tasks such as responding to an email.
13. Subject had used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
14. Subject had a current sleep disorder.
15. Subject had a history of cataracts, active glaucoma or any other ophthalmic condition that could interfere with the eye blink assessment.
16. Subject had veins unsuitable for venepuncture and/or cannulation.
17. Subject had a corrected QT interval using Fridericia's correction \>450 milliseconds.
18. Subject was unlikely to cooperate with the requirements of the study, in the opinion of the PI or designee.
19. Subject was pregnant or lactating
20. Exclusion Part 2 only: Subject had a history of drug abuse or dependence in the last 12 months, had current drug abuse or dependence or had a positive result for drugs of abuse and alcohol tests at screening or admission.
B. Psychiatric Health
21. Subject had a current or past history of meeting Diagnostic and Statistical Manual of Mental Disorders fourth edition criteria for schizophrenia or other psychotic disorders (unless substance induced or due to a medical condition), bipolar I or II disorder, a major depressive episode, a manic or hypomanic episode, alcohol dependence or abuse (in the past 5 years), substance dependence and abuse (in the past 5 years), current panic disorder, obsessive compulsive disorder, social anxiety disorder, generalised anxiety disorder, anorexia, bulimia or post-traumatic stress disorder
22. Subject had a first- or second-degree relative with schizophrenia, other psychotic disorders (unless substance-induced or due to a medical condition), or bipolar I or II disorder.
23. Subject was receiving chronic administration of tricyclic antidepressants or lithium or acute administration of serotonin reuptake inhibitors, haloperidol, serotonin reuptake inhibitors or monoamine oxidase inhibitors.
24. Subject was taking OTC doses of 5-hydroxytryptophan or St John's Wort or ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05674669
Study Brief:
Protocol Section:
NCT05674669