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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421105
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Eleusis Therapeutics

Tracking Information
First Submitted Date  ICMJE May 7, 2020
First Posted Date  ICMJE June 9, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE June 29, 2015
Actual Primary Completion Date October 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • To evaluate the safety and tolerability of very low dose LSD [ Time Frame: 2.5 weeks ]
    Assessment of Adverse Events by % frequency
  • To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time [ Time Frame: 12 hours ]
    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.
  • To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug [ Time Frame: 12 hours ]
    Cmax (pg/mL): maximum drug plasma concentration
  • To evaluate the pharmacokinetics of very low dose LSD - Half life of drug [ Time Frame: 12 hours ]
    Tmax (h): time to reach maximum plasma concentration Tlag (h): time for drug to appear in plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2020)
  • To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition. [ Time Frame: 2.5 weeks ]
    The CANTAB (Cambridge Neuropsychological Test Automated Battery ) included four test that measured cognitive function. These were Reaction Time (RTI) for reaction times, Paired Associates Learning (PAL) for visual memory and learning, Rapid Visual Information Processing (RVP) for sustained memory, Spatial Working Memory (SWM) for retention of visuospatial information.
  • To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects. [ Time Frame: 2.5 weeks ]
    Assessed by the Visual Analog Scale (VAS). Items assess acute subjective drug effects (e.g. intensity, liking) Item scores are assessed on a visual scale ranging from 1% to 100%. Higher scores indicate greater subjective effects
  • To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire [ Time Frame: 2.5 weeks ]
    5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). The scale ranges from no, not more than usual (on the left) to yes, very much more than usual (on the right). Items retrospectively assess subjective drug effects. Item scores are assessed on a visual scale ranging from 1% to 100%. Higher scores indicate greater subjective effects associated with a different state of consciousness
  • To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking [ Time Frame: 2.5 weeks ]
    Static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™)
  • To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception [ Time Frame: 2.5 weeks ]
    The ability to sense stimuli arising within the body regarding position and motion will be measured in 15 trials during which the participant will have their arm rotated to set angles and asked to reproduce the angle while blindfolded. Performance is measured as the absolute error between the target and matching angle.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 4, 2020)
Exploratory Objective To evaluate the pharmacokinetic (PK)/PD relationship between very low dose LSD concentration and cognitive changes. [ Time Frame: 2.5 weeks ]
The relationship between LSD plasma concentration, selected PK parameters and cumulative effects of repeated LSD administration was evaluated using correlation and/or linear regression methods to evaluate possible associations with changes in cognition or affect.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years
Official Title  ICMJE A Phase 1,Single-centre, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Very Low Dose LSD (5 µg, 10 µg, 20 µg) in Healthy Volunteers Aged 55-75 Years
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.
Detailed Description

The magnitude of the effect of LSD was explored across specific PD measures.

These included:

  • Cognition and affect, including evaluation of memory, temporal perception, executive function, and learning
  • Subjective effects
  • Proprioception and balance
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Lysergic acid diethylamide (LSD) 5µg
  • Drug: Lysergic acid diethylamide (LSD) 10µg
  • Drug: Lysergic acid diethylamide (LSD)20 µg
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Group 1 N=12
    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.
    Intervention: Drug: Lysergic acid diethylamide (LSD) 5µg
  • Experimental: Group 2 N=12
    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.
    Intervention: Drug: Lysergic acid diethylamide (LSD) 10µg
  • Experimental: Group 3 N=12
    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.
    Intervention: Drug: Lysergic acid diethylamide (LSD)20 µg
  • Placebo Comparator: Group 4 N=12
    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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2020)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 5, 2015
Actual Primary Completion Date October 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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.

Exclusion Criteria:

  • General Health

    1. 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.
    2. 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
    3. Subject has a presence or relevant history of organic brain disorders (e.g. intracranial hypertension, impaired consciousness, lethargy, and brain tumour).
    4. Subject has a relevant history of atopy, hypersensitivity, skin allergies or allergic reactions to drugs.
    5. Subject has a clinical laboratory test result outside the reference ranges of the testing laboratory and considered clinically significant by the investigator.
    6. Subject is positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or human immunodeficiency virus I and II at screening.
    7. Subject is a current smoker. (Has not smoked for at least 1 month prior to the screening visit).
    8. 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.
    9. Subject has a medical history that would affect the subject's safety or the study endpoints.
    10. 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.
    11. 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.
    12. Subject has donated or received any blood or blood products within the previous 3 months prior to first dosing.
    13. Subject cannot use a computer at the required minimum level.
    14. Subject has used any investigational drug or participated in any clinical trial within 3 months of their first dosing.
    15. Subject has a current sleep disorder.
    16. Subject has a history of cataracts, active glaucoma or any other ophthalmic condition that could interfere with the eye blink assessment.
    17. Subject has a hearing loss of more than 40 dB. Subjects with > 40dB hearing loss at less than 1500Hz were excluded Subjects with > 40dB hearing loss at 1500Hz or higher can be included in the study. The hearing result from the ear with the best hearing. Provided one ear can hear at the above levels then the patient can be included.
    18. Subject has veins unsuitable for venipuncture and/or cannulation.
    19. Subject has a corrected QT interval using Fridericia's correction >450 milliseconds at any single reading.
    20. Subject is unlikely to co-operate with the requirements of the study, in the opinion of the Principal Investigator (PI) or designee.

B. Psychiatric health

  1. Based on the modified SCID-CT, a subject with the lifetime presence of any of the following is excluded: psychotic symptoms that are not substance-induced or due to a medical condition or has 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 on any substance in the past 5 years; current diagnosis of obsessive-compulsive disorder (OCD), dysthymic disorder, panic disorder, anorexia, and bulimia.
  2. Subject is receiving chronic administration of tricyclic antidepressants or lithium or acute administration of selective serotonin reuptake inhibitors (SSRIs) or haloperidol, or serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors.
  3. Subject is taking OTC doses of 5-HT or St John's Wort or Ayahuasca (which contains monoamine oxidase inhibitors in addition to dimethyltryptamine [DMT]).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04421105
Other Study ID Numbers  ICMJE CAS-50-37-3-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eleusis Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eleusis Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Research and Development Director Eleusis Therapeutics
PRS Account Eleusis Therapeutics
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP