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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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
of LSD.

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.

Inclusion Criteria:

- Have a diagnosis of advanced-stage potentially fatal illness. As well as metastatic
cancer this may include autoimmune, neurological, infectious or rheumatoid diseases
as well. The participant must have a probability of survival of more than six months.
The estimated life expectancy in relation to the study must be documented.

- The participant makes the decision to participate in the study by his or her own will
and that there is no inhibition to his or her will or ability of deciding due to the
primary disease.

- Meet DSM-IV criteria for Anxiety Disorder as indicated by the SCID or have a score of
at least 40 on each part of the STAI.

- Have failed to respond adequately or at all to medication or psychotherapy intended
to reduce anxiety, or have refused to take anxiolytic medication.

- May be diagnosed with another affective disorder other than anxiety disorder, except
bipolar-I disorder.

- Are at least 18 years of age.

- Are willing to commit to medication dosing, experimental sessions, follow-up
sessions, and to complete evaluation instruments (although they may withdraw from the
study at any time without cause).

- Are willing to withdraw from taking any psychiatric medications during the
experimental session period. Drugs must be discontinued long enough before the first
LSD treatment session to avoid the possibility of a drug-drug interaction (the
interval will be at least 5 times the particular drug's half-life).

- If in ongoing psychotherapy, those recruited into the study may continue to see their
outside therapist, provided they sign a release for the investigators to communicate
directly with their therapist. Participants should not change therapists, increase or
decrease the frequency of therapy or commence any new type of therapy until after the
evaluation session 2 months after the second LSD treatment session.

- Participants must agree that, for one week preceding each LSD treatment session:

- a. Clinical judgment will be used to determine permissible herbal supplements.

- b. They will not initiate any new prescription medications (except with prior
approval of the research team).

- c. Clinical judgment will be used to determine permissible nonprescription

- Participants must be willing to follow restrictions and guidelines concerning
consumption of food, beverages and nicotine the night before and just prior to each
LSD session.

Exclusion Criteria:

- Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control.

- Anyone with past or present diagnosis with a primary psychotic disorder.

- Meeting DSM-IV criteria for Dissociative Disorder or Bipolar-I Affective Disorder.

- Meeting DSM-IV criteria for abuse of or dependence on any substance (other than
caffeine or nicotine) in the past 60 days.

- Diagnosed with significant somatic problems, that in the clinical judgment of the
investigators poses too great a potential for side effects.

- No sufficient liver function at the baseline examination or the day before the
experimental sessions.

- Having evidence of CNS affection from the primary disease (e.g. brain metastasis),
shown by neurocognitive impairment.

- Weighing less than 45 kg.

- Reasonably judged to present a serious suicide risk or who are likely to require
psychiatric hospitalization during the course of the study.

- Unable to fully understand the potential risks and benefits of the study and give
informed consent.

- Requiring ongoing concomitant therapy with a psychotropic drug (other than as needed,
anxiety medications, and pain control medications) and are unable or unwilling to
comply with the washout period.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Spielberger State-Trait Inventory (STAI)

Outcome Description:

Self-report measure of trait and current anxiety

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Peter Gasser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Private practices of Peter Gasser; Swiss Medical Association for Psycholytic Therapy (SAPT)


Switzerland: Swissmedic

Study ID:




Start Date:

February 2008

Completion Date:

September 2012

Related Keywords:

  • Anxiety
  • Anxiety
  • quality of life
  • psychotherapy
  • potentially fatal illness
  • lysergic acid diethylamide
  • Anxiety Disorders