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Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01878942
First received: May 27, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to characterize the acute psychological, physiological, endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: LSD
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Subjective / psychological effects of LSD [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    repeated assessment of subjective effects with validated questionnaires


Secondary Outcome Measures:
  • Physiological effects of LSD [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Effect on blood pressure, heart rate, body temperature, and pupillary function

  • Endocrine response of LSD [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics of LSD [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship

  • Effect of LSD on prepulse inhibition [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Pre-Pulse inhibition of the acoustic startle reflex

  • Tolerability of LSD [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Assessment of adverse effects

  • Long-term psychological effects of LSD [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessment of long-term psychological effects after 1 and 12 months

  • Genetic Polymorphisms [ Time Frame: assessed once, at time of screening visit or at time of end of study visit ] [ Designated as safety issue: No ]
    Effects of genetic polymorphisms on the response to LSD

  • Effects on social cognition and empathy [ Time Frame: 8 h ] [ Designated as safety issue: No ]
    assessment of cognitive and emotional empathy, as well as of prosocial behaviour


Enrollment: 16
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo, LSD
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two treatment conditions in the same subject.
Drug: Placebo

Capsules containing mannitol looking identical to LSD

per os

Drug: LSD
200µg per os, single dose
Other Name: Lysergic acid diethylamide

Detailed Description:

Lysergic acid diethylamide (LSD) is the prototype hallucinogen used recreationally worldwide. In the 50-70s, LSD was also used to study psychotic-like states in normals ("model psychosis") and in "psycholytic psychotherapy". Potential research and therapeutic uses of LSD are now re-recognized and may include its use in brain research, treatment of cluster headache, and aid in psychotherapy and in terminally ill patients. A better and contemporary understanding of the pharmacology of LSD is important in the light of its widespread recreational, and potential scientific and therapeutic uses. The study has no primary therapeutic intentions but aims for a solid account of the clinical pharmacological characteristics of the drug. To characterize the acute physiological, psychological, endocrine, and pharmacological response to the administration of a single dose of LSD in healthy subjects the investigators use a randomized double-blind placebo-controlled cross-over design with two experimental sessions. Subjects will participate in a placebo and a LSD session. Subjective and cardiovascular responses will be repeatedly assessed throughout the experiments and plasma samples are collected for pharmacokinetics and endocrine measurements.Additionally long-term psychological changes associated with the LSD experience are assessed.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age between 25 and 65 years
  2. Understanding of the German language
  3. Understanding the procedures and the risks associated with the study
  4. Participants must be willing to adhere to the protocol and sign the consent form
  5. Participants must be willing to refrain from taking illicit psychoactive substances during the study
  6. Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day.
  7. Participants must be willing not to drive a traffic vehicle within 48 h following LSD administration.
  8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.

Exclusion Criteria:

  1. Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>150/95 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
  2. Current or previous psychotic or major affective disorder
  3. Psychotic or major affective disorder in first-degree relatives
  4. Relevant prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 10 times or any time within the previous 2 months.
  5. Pregnant or nursing women.
  6. Participation in another clinical trial (currently or within the last 30 days)
  7. Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  8. Insufficient interpersonal relationship/rapport with study physician as judged by the study physician
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878942

Locations
Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01878942     History of Changes
Other Study ID Numbers: EK 279/12
Study First Received: May 27, 2013
Last Updated: July 14, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
LSD
Pharmacology
Pharmacokinetics
Pharmacodynamics
Mechanism of action
Psychedelic
Serotonin
Prepulse inhibition
LSD-induced neuroendocrine effects
Long-term psychological effects

Additional relevant MeSH terms:
Lysergic Acid Diethylamide
Central Nervous System Agents
Hallucinogens
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Receptor Agonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014