Status:
COMPLETED
Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Healthy
Eligibility:
All Genders
25-65 years
Phase:
EARLY_PHASE1
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 "psy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01878942
Start Date
June 1 2013
End Date
December 1 2014
Last Update
January 21 2016
Active Locations (1)
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1
University Hospital Basel
Basel, Canton of Basel-City, Switzerland, 4031