Clinical TrialHealthy VolunteersLSDLSDLSDPlaceboCompleted

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

Phase I double-blind, placebo-controlled, randomised study (n=48) of very low-dose LSD (5, 10, 20 µg) or placebo given six times over 21 days in healthy volunteers aged 55–75.

Target Enrollment
48 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group study comparing three very-low-dose LSD regimens (5, 10, 20 µg) to placebo; dosing on Study Days 1, 5, 9, 13, 17 and 21 with a follow-up ~4 weeks after last dose.

Outcomes explored pharmacodynamic effects on cognition, affect, memory, temporal perception, executive function, learning, subjective effects, proprioception and balance, plus safety and tolerability measures.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

LSD 5 µg

experimental

Very-low-dose LSD 5 µg given six times over 21 days (days 1,5,9,13,17,21).

Interventions

  • LSD5 µg
    via Oral• six doses over 21 days• 6 doses total

LSD 10 µg

experimental

Very-low-dose LSD 10 µg given six times over 21 days (days 1,5,9,13,17,21).

Interventions

  • LSD10 µg
    via Oral• six doses over 21 days• 6 doses total

LSD 20 µg

experimental

Very-low-dose LSD 20 µg given six times over 21 days (days 1,5,9,13,17,21).

Interventions

  • LSD20 µg
    via Oral• six doses over 21 days• 6 doses total

Placebo

inactive

Matching placebo given on same schedule (6 doses over 21 days).

Interventions

  • Placebo
    via Oral• six doses over 21 days• 6 doses total

    Matching placebo

Participants

Ages
55 – 75
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. 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).
  • 2. 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.
  • 4. A female subject is eligible to participate if she is postmenopausal (has experienced 12 consecutive months without menstruation).
  • 5. A male subject with a female partner is eligible to participate if he agrees to use a double barrier method of contraception from the time of the first dose until 3 months post-last dose; male subjects must not donate sperm for 3 months following the last dose of study medication.

Exclusion Criteria

  • Exclusion Criteria:
  • General Health
  • 1. 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.
  • 2. Resting BP exceeding 160 mmHg (systolic) or 90 mmHg (diastolic) averaged across 4 assessments taken on the same day.
  • 3. Presence or relevant history of organic brain disorders (e.g. intracranial hypertension, impaired consciousness, lethargy, brain tumour).
  • 4. Relevant history of atopy, hypersensitivity, skin allergies or allergic reactions to drugs.
  • 5. Clinical laboratory test result outside reference ranges considered clinically significant by the investigator.
  • 6. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody or HIV I/II at screening.
  • 7. Current smoker (has not smoked for at least 1 month prior to the screening visit).
  • 8. History of drug abuse/dependence in the last 12 months or current drug abuse/dependence, or positive drug/alcohol tests at screening/baseline.
  • 9. Medical history that would affect safety or study endpoints.
  • 10. Use of prescription drugs or therapy within 7 days of first dosing unless agreed as non-clinically relevant by the investigator and Medical Monitor.
  • 11. Use of OTC medication or therapy, including mega-dose vitamin therapy (excluding routine vitamins), within 7 days of first dosing unless agreed non-clinically relevant.
  • 12. Donated or received any blood or blood products within the previous 3 months prior to first dosing.
  • 13. Cannot use a computer at the required minimum level.
  • 14. Use of any investigational drug or participation in any clinical trial within 3 months of first dosing.
  • 15. Current sleep disorder.
  • 16. History of cataracts, active glaucoma or ophthalmic condition that could interfere with eye blink assessment.
  • 17. Hearing loss >40 dB (best ear) at frequencies <1500 Hz excluded; >40 dB at 1500 Hz or higher may be included if one ear meets levels.
  • 18. Veins unsuitable for venipuncture and/or cannulation.
  • 19. Corrected QT interval (Fridericia) >450 ms at any single reading.
  • 20. Unlikely to cooperate with study requirements in the opinion of the PI or designee.
  • Psychiatric health
  • 1. Based on the modified SCID-CT, lifetime presence of psychotic symptoms not substance-induced or due to a medical condition, or a first- or second-degree relative with these disorders; any manic or hypomanic episode; lifetime presence of any major depressive episode; lifetime presence of substance abuse or dependence in the past 5 years; current diagnosis of OCD, dysthymic disorder, panic disorder, anorexia or bulimia.
  • 2. Receiving chronic tricyclic antidepressants or lithium, or acute administration of SSRIs, haloperidol, SNRIs or MAOIs.
  • 3. Taking OTC 5-HT agents, St John's Wort or ayahuasca.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2015-06-29
    End: 2015-11-05
  • Compounds
    LSDLSDLSDPlacebo
  • Topic
    Healthy Volunteers

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