- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865653
LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects (LSD-Bio)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
LSD is widely used for recreational and spiritual purposes. Additionally LSD is currently reused in experimental studies with healthy subjects and in studies investigating its effects on patients suffering from anxiety, depression, addiction personality disorders, cluster headache, migraine, and other pathological conditions.
When LSD is used recreationally, it is administered mostly in the form of LSD tartrate on filter paper (blotter) or as a liquid. In experimental research over the past years, LSD has mostly been used in the form of LSD base, which is lipophilic and therefore has typically been administered as a solution in ethanol. However, some researchers have also use LSD tartrate orally or LSD base intravenously. Currently, it is not clear how these different forms of LSD compare regarding their bioequivalence and effects.
The present study therefore compares four different formulations of LSD and placebo: (1) An oral drinking solution of LSD base currently used in many research studies (100 μg LSD in 96% ethanol), (2) A solid orodispersible film containing LSD base (100 μg LSD), (3) LSD tartrate used in research and recreationally (100 μg LSD equivalent of LSD tartrate in water), (4) an intravenous administration of LSD tartrate (100 μg LSD equivalent of LSD tartrate in water), and (5) placebo for all formulations (quadruple-dummy). The primary goals are to document the bioequivalence of LSD base (1) and tartrate (3) and to define the oral bioavailability of LSD using an additional intravenous LSD administration.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Matthias E Liechti, MD
- Phone Number: +41 061 328 68 68
- Email: matthias.liechti@usb.ch
Study Contact Backup
- Name: Friederike Holze, MSc
- Phone Number: +41 061 556 54 37
- Email: friederike.holze@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Clinical Pharmacology & Toxicology, University Hospital Basel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 25 and 65 years old
- Sufficient understanding of the German language
- Understanding of procedures and risks associated with the study
- Willing to adhere to the protocol and signing of the consent form
- Willing to refrain from the consumption of illicit psychoactive substances during the study
- Abstaining from xanthine-based liquids from the evenings prior to the study sessions to the end of the study days
- Willing not to operate heavy machinery within 48 hours after substance administration
- Willing to use double-barrier birth control throughout study participation
- Body mass index between 18-29 kg/m2
Exclusion Criteria:
- Chronic or acute medical condition
- Current or previous major psychiatric disorder
- Psychotic disorder or bipolar disorder in first-degree relatives
- Hypertension (>140/90 mmHg) or hypotension (SBP<85 mmHg)
- Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
- Pregnancy or current breastfeeding
- Participation in another clinical trial (currently or within the last 30 days)
- Use of medication that may interfere with the effects of the study medication
- Tobacco smoking (>10 cigarettes/day)
- Consumption of alcoholic beverages (>20 drinks/week)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral drinking solution of LSD base
Oral drinking solution of 0.1 mg LSD base in 96% ethanol
|
A moderate dose of 0.1 mg LSD will be administered.
Other Names:
|
Experimental: Solid orodispersible film containing LSD base
Solid orodispersible film containing 0.1 mg LSD base
|
A moderate dose of 0.1 mg LSD will be administered.
Other Names:
|
Experimental: Oral drinking solution of LSD tartrate
Oral drinking solution of 0.146 mg LSD tartrate in water
|
A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
Other Names:
|
Experimental: Intravenous administration of LSD tartrate
Intravenous administration of 0.146 mg LSD tartrate in water
|
A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
Other Names:
|
Placebo Comparator: Placebo
Placebo for all formulations
|
Placebo for each formulation containing only the solvent or gel but no LSD.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LSD plasma AUC
Time Frame: 18 months
|
Assessed 22 times on each study day via blood samples
|
18 months
|
LSD Cmax
Time Frame: 18 months
|
Assessed 22 times on each study day via blood samples
|
18 months
|
Bioavailability of LSD base
Time Frame: 18 months
|
Assessed 22 times on each study day via blood samples
|
18 months
|
Bioavailability of LSD tartrate
Time Frame: 18 months
|
Assessed 22 times on each study day via blood samples
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NEO-Five-Factor-Inventory (NEO-FFI)
Time Frame: Baseline
|
The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness.
It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
|
Baseline
|
Freiburger Personality Inventory (FPI-R)
Time Frame: Baseline
|
The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism).
It uses a 2-point scale ("true" and "not true").
|
Baseline
|
Saarbrücker Personality Questionnaire (SPF)
Time Frame: Baseline
|
The SPF defines empathy as the "reactions of one individual to the observed experiences of another."
It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well".
The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
|
Baseline
|
HEXACO personality inventory
Time Frame: Baseline
|
The HEXACO personality inventory is a six-dimensional model of human personality with 100 items.The six factors are: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness and Openness to Experience.
The HEXACO uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
|
Baseline
|
Defense Style Questionnaire (DSQ-40)
Time Frame: Baseline
|
The DSQ-40 can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature".
Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
|
Baseline
|
Acute subjective effects I
Time Frame: 18 months
|
Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale from 0% - 100% with higher scores representing more intense effects
|
18 months
|
Acute subjective effects II
Time Frame: 18 months
|
5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects
|
18 months
|
Acute subjective effects III
Time Frame: 18 months
|
Spiritual Realm Questionnaire assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales
|
18 months
|
Acute subjective effects IV
Time Frame: 18 months
|
States of Consciousness Questionnaire assesses the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
|
18 months
|
Autonomic effects I
Time Frame: 18 months
|
Assessed 23 times on each study day via systolic and diastolic blood pressure
|
18 months
|
Autonomic effects II
Time Frame: 18 months
|
Assessed 23 times on each study day via heart rate
|
18 months
|
Autonomic effects III
Time Frame: 18 months
|
Assessed 23 times on each study day via tympanic body temperature
|
18 months
|
Bioavailability of orodispersible film
Time Frame: 18 months
|
Assessed 22 times on each study day via blood samples
|
18 months
|
Absence of tolerance
Time Frame: 18 months
|
Absence of tolerance (no significant order effect) with repeated dosing of LSD with a between dosing interval of at least 10 days assessed with Visual Analog Scales (any drug response over time)
|
18 months
|
Appreciation Scale (AS)
Time Frame: Baseline
|
The Appreciation Scale comprises 57 items used to measure eight aspects of appreciation.
The eight subscales are respectively focus on what one has ("Have" Focus), Awe, Ritual, Present Moment, Self/Social Comparison, Gratitude, Loss/Adversity, and Interpersonal.
Each item is evaluated on a scale from 1 to 7 in terms of either attitude intensity ("strongly disagree" to "strongly agree") or frequency ("never" to "more than once a day").
|
Baseline
|
Subjective well-being I
Time Frame: 18 months
|
The Scale of Positive and Negative Experience (SPANE) is a 12-item questionnaire to capture the affective component of subjective well-being.
It includes six items to assess positive feelings and six items to assess negative feelings.
The feelings are reported on a 5-point scale ranging from "very rarely" to "very often or always".
|
18 months
|
Subjective well-being II
Time Frame: 18 months
|
The Positive Attitude towards life is an 8-item subscale of the 39-item Bern Subjective Well-Being Questionnaire and assesses different dimensions of subjective well-being.
Evaluations are made using a six-point rating scale ranging from 1 ("strongly disagree") to 6 ("strongly agree").
|
18 months
|
Subjective well-being III
Time Frame: 18 months
|
Global Life Satisfaction (GLS) is assessed on a single item life satisfaction measure.
The question is answered on a 11-point scale with 0 as "not at all satisfied with your life" and 10 " completely satisfied.
|
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthias E Liechti, MD, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC 2020-02331
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Lysergic Acid Diethylamide Base oral drinking solution
-
Eleusis TherapeuticsCompleted
-
Eleusis TherapeuticsCompleted
-
Radboud University Medical CenterLeiden University Medical Center; ZonMw: The Netherlands Organisation for Health... and other collaboratorsNot yet recruitingChronic Cluster Headache
-
University Hospital, Basel, SwitzerlandCompleted
-
University Hospital, Basel, SwitzerlandUniversity Hospital, ZürichRecruitingDepression | Quality of Life | Pain | Anxiety | Caregiver Burden | Psychological Distress | Palliative Care | Demoralization | Fear of Death | Existential DistressSwitzerland
-
Multidisciplinary Association for Psychedelic StudiesCompleted
-
Psychiatric University Hospital, ZurichCompleted
-
Maastricht UniversityRecruitingProsocial BehaviorNetherlands
-
Rigshospitalet, DenmarkRecruiting
-
University of FribourgRecruiting