A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years

NCT04421105 | Completed Phase 1

• 1 other identifier: CAS-50-37-3-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was a Phase 1, double-blind, placebo-controlled, randomised study of very low dose LSD. Healthy volunteers aged 55 to 75 years with no use of LSD in the past 5 years were screened within 28 days of randomization. Subjects who met all inclusion and no exclusion criteria and provided written informed consent were randomised a 1:1:1:1 ratio to receive 6 doses of 5 µg, 10 µg, or 20 µg LSD or placebo, at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose of LSD. A total of 48 subjects were enrolled.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• To evaluate the safety and tolerability of very low dose LSD

  Assessment of Adverse Events by % frequency

  2.5 weeks

• To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time

  AUC 0-12h ( pg/mL\*h): area under the plasma concentration-time curve profiles from time zero to the 12 hour sample determined using the linear trapezoidal rule.

  12 hours

• To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug

  Cmax (pg/mL): maximum drug plasma concentration

  12 hours

• To evaluate the pharmacokinetics of very low dose LSD - Half life of drug

  Tmax (h): time to reach maximum plasma concentration Tlag (h): time for drug to appear in plasma

  12 hours

Secondary Outcomes (5)

• To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition.

  2.5 weeks

• To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects.

  2.5 weeks

• To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire

  2.5 weeks

• To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking

  2.5 weeks

• To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception

  2.5 weeks

Other Outcomes (1)

• Exploratory Objective To evaluate the pharmacokinetic (PK)/PD relationship between very low dose LSD concentration and cognitive changes.

  2.5 weeks

Study Arms (4)

Group 1 N=12

EXPERIMENTAL

6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.

Drug: Lysergic acid diethylamide (LSD) 5µg

Group 2 N=12

EXPERIMENTAL

6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.

Drug: Lysergic acid diethylamide (LSD) 10µg

Group 3 N=12

EXPERIMENTAL

6 doses at 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.

Drug: Lysergic acid diethylamide (LSD)20 µg

Group 4 N=12

PLACEBO COMPARATOR

6 doses 4-day intervals for 21 days (on Study Days 1, 5, 9, 13, 17, and 21). A follow-up visit was conducted approximately 4 weeks after the last dose.

Drug: Placebo

Interventions

Lysergic acid diethylamide (LSD) 5µg DRUG

Group 1 N=12

Lysergic acid diethylamide (LSD) 10µg DRUG

Group 2 N=12

Lysergic acid diethylamide (LSD)20 µg DRUG

Group 3 N=12

Placebo DRUG

Group 4 N=12

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Healthy male or female subjects aged 55 to 75 years, inclusive (site staff endeavoured to achieve a median age of 65 years across all subjects).
• \. Subject has not been previously exposed to LSD within the past 5 years. 3. Subject is 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 study protocol, and clearly and reliably communicate their subjective symptoms to the Investigator.
• \. A female subject is eligible to participate if she is postmenopausal (has experienced 12 consecutive months without menstruation).
• \. A male subject with a female partner is eligible to participate if he agrees to use a double barrier method of contraception. This criterion must be followed from the time of the first dose of study medication until 3 months post-last dose. Male subjects must not donate sperm for 3 months following the last dose of study medication.

You may not qualify if:

• General Health
• Subject has a history or evidence of clinically relevant psychiatric, respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as judged by the investigator.
• Subject has resting BP exceeding 160 mmHg (systolic) and 90 mmHg (diastolic), averaged across 4 assessments taken on the same day. BP measurements were taken at least 1 min apart
• Subject has a presence or relevant history of organic brain disorders (e.g. intracranial hypertension, impaired consciousness, lethargy, and brain tumour).
• Subject has a relevant history of atopy, hypersensitivity, skin allergies or allergic reactions to drugs.
• Subject has a clinical laboratory test result outside the reference ranges of the testing laboratory and considered clinically significant by the investigator.
• Subject is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus I and II at screening.
• Subject is a current smoker. (Has not smoked for at least 1 month prior to the screening visit).
• Subject has a history of drug abuse/dependence in the last 12 months or has a current drug abuse/dependence, and/or is positive for drugs of abuse and alcohol tests at screening and/or baseline.
• Subject has a medical history that would affect the subject's safety or the study endpoints.
• Subject has used prescription drugs or therapy within 7 days of first dosing, unless agreed as non clinically relevant by the investigator and the Medical Monitor.
• Subject has used over the counter (OTC) medication or therapy, including mega-dose vitamin therapy (but excluding routine vitamins) within 7 days of first dosing, unless agreed as non clinically relevant by the investigator and the Medical Monitor.
• Subject has donated or received any blood or blood products within the previous 3 months prior to first dosing.
• Subject cannot use a computer at the required minimum level.
• Subject has used any investigational drug or participated in any clinical trial within 3 months of their first dosing.

Sponsors & Collaborators

• Eleusis Therapeutics: lead

Related Links

• Study publication

MeSH Terms

Interventions

Lysergic Acid Diethylamide

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Research and Development Director

  Eleusis Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: June 9, 2020
• Study Start: June 29, 2015
• Primary Completion: October 30, 2015
• Study Completion: November 5, 2015
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share