A Dose-Ranging Study of 50 µg to 100 µg LSD in... — Clinical Trial Details

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

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.

Company

Product

Legal

A Dose-Ranging Study of 50 µg to 100 µg LSD in Healthy Volunteers

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Safety, tolerability, pharmacokinetics, and subjective effects of 50, 75, and 100 µg LSD in healthy participants within a novel intervention paradigm: A proof-of-concept study

Integration

Study Arms & Interventions

50 µg LSD

Interventions

75 µg LSD

Interventions

100 µg LSD

Interventions

Placebo → 75 µg

Interventions

50 µg → 75 µg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details