LSD-assisted Psychotherapy in Persons Suffering From Anxiety Associated With Advanced-stage Life Threatening Diseases. A Phase-II, Double-blind, Placebo-controlled Dose-response Pilot Study
Diagnosis with a potentially fatal illness is distressing and can provoke anxiety that
further reduces quality of life, and a treatment that reduces anxiety when facing
deteriorating health and mortality will improve quality of life for people with such
illnesses. Forty to fifty years ago, researchers investigated lysergic acid diethylamide
(LSD) in combination with psychotherapy to treat anxiety when facing advanced stage cancer.
This psychedelic (hallucinogenic) drug can produce transformative or mystical experiences
and insights that can help in anxiety reduction. This study will be a randomized, active
placebo controlled,double-blind pilot study of the safety and efficacy of LSD-assisted
psychotherapy as a way of reducing anxiety in people with potentially fatal illnesses. This
study will examine whether two sessions of LSD-assisted psychotherapy scheduled two to four
weeks apart will reduce anxiety and improve quality of life for people experiencing anxiety
as a result of a potentially fatal illness.
Study subjects will receive either 200 or 20 mcg (micrograms) LSD during two day-long
psychotherapy sessions scheduled two to four weeks apart. Subjects in this study will have a
66% of receiving the full dose of 200 mcg LSD, and they have a 33% chance of getting the
active placebo dose of 20 mcg LSD. Neither the researchers nor the subject will know whether
he got 200 or 20 mcg LSD. Upon participant agreement, all psychotherapy sessions will be
recorded to audio and video.
The randomized part of the study will last three and a half months (14 weeks).
People who learn they got the active placebo dose of LSD during the randomized phase can go
on to to take part in an "open label" study phase, where they will get the full dose of LSD
during two day-long psychotherapy sessions scheduled two to four weeks apart. "Open label"
means that they and the researchers will both be aware that they are getting the full dose
Participants who received the full dose of LSD and took part in all study visits will be
assessed for symptoms of anxiety and depression and quality of life 12 months after their
final experimental session.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Spielberger State-Trait Inventory (STAI)
Self-report measure of trait and current anxiety
Baseline, experimental session 1, psychotherapy between experimental session 1 and experimental session 2, experimental session 2, psychotherapy 1 wk after experimental session 2, two months after second experimental session
Peter Gasser, MD
Private practices of Peter Gasser; Swiss Medical Association for Psycholytic Therapy (SAPT)