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

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LSD

• Registration Number: NCT01878942
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2013-05-27
• Study Start: 2013-06
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-17
• Primary Completion: 2014-02
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo, LSD	Placebo	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.
Placebo, LSD	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.

Primary Outcome Measures

Name	Time	Method
Subjective / psychological effects of LSD	24 hours	repeated assessment of subjective effects with validated questionnaires

Secondary Outcome Measures

Name	Time	Method
Physiological effects of LSD	24 hours	Effect on blood pressure, heart rate, body temperature, and pupillary function
Endocrine response of LSD	24 hours
Pharmacokinetics of LSD	24 hours	Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship
Effect of LSD on prepulse inhibition	3 hours	Pre-Pulse inhibition of the acoustic startle reflex
Tolerability of LSD	24 hours	Assessment of adverse effects
Genetic Polymorphisms	assessed once, at time of screening visit or at time of end of study visit	Effects of genetic polymorphisms on the response to LSD
Long-term psychological effects of LSD	12 months	Assessment of long-term psychological effects after 1 and 12 months
Effects on social cognition and empathy	8 h	assessment of cognitive and emotional empathy, as well as of prosocial behaviour

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland