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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT01878942

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo Drug: LSD	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Lysergic acid diethylamide

Arm

Intervention/Treatment

Other: 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 Names:

Lysergic acid diethylamide

Outcome Measures

Primary Outcome Measures

Subjective / psychological effects of LSD [24 hours]
repeated assessment of subjective effects with validated questionnaires

Secondary Outcome Measures

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
Long-term psychological effects of LSD [12 months]
Assessment of long-term psychological effects after 1 and 12 months
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
Effects on social cognition and empathy [8 h]
assessment of cognitive and emotional empathy, as well as of prosocial behaviour

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age between 25 and 65 years
Understanding of the German language
Understanding the procedures and the risks associated with the study
Participants must be willing to adhere to the protocol and sign the consent form
Participants must be willing to refrain from taking illicit psychoactive substances during the study
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.
Participants must be willing not to drive a traffic vehicle within 48 h following LSD administration.
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:

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.
Current or previous psychotic or major affective disorder
Psychotic or major affective disorder in first-degree relatives
Relevant prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 10 times or any time within the previous 2 months.
Pregnant or nursing women.
Participation in another clinical trial (currently or within the last 30 days)
Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
Insufficient interpersonal relationship/rapport with study physician as judged by the study physician