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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 December 2018
Main ID:  NCT03153579
Date of registration: 09/05/2017
Prospective Registration: Yes
Primary sponsor: University Hospital, Basel, Switzerland
Public title: LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders LSD-assist
Scientific title: LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study
Date of first enrolment: May 31, 2017
Target sample size: 40
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03153579
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Switzerland
Contacts
Name:     Matthias E Liechti, MD, MAS
Address: 
Telephone: + 41 61 265 2525
Email: matthias.liechti@usb.ch
Affiliation: 
Name:     Peter Gasser, MD
Address: 
Telephone:
Email:
Affiliation:  Private Practice
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age > 25 years.

2. Meet DSM-IV criteria for anxiety disorder as indicated by the Structured Clinical
Interview for the DSM (SCID)-IV or have a score of at least 40 on the state- or trait
STAI scale at study inclusion.

3. 40% or more of the participants should have a diagnosis of advanced-stage potentially
fatal illness (autoimmune, neurological, or cancer without central nervous system
(CNS) involvement). Patients should be ambulatory and not terminal and likely to have
a roughly estimated life expectancy of > twelve months.

4. Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria
for anxiety disorder (elevated STAI score not sufficient for inclusion)

5. Sufficient understanding of the study procedures and risks associated with the study.

6. Participants must be willing to adhere to the study procedures and sign the consent
form.

7. Participants are willing to refrain from taking any psychiatric medications during the
experimental session period. If they are being treated with antidepressants or are
taking anxiolytic medications on a fixed daily regimen such drugs must be discontinued
long enough before the LSD/placebo 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 [typically 3-7 days]).

8. 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 during the study
(not including the follow-up).

9. Participants must also refrain from the use of any psychoactive drugs, with the
exception of the long term pain medication or caffeine or nicotine, within 24 hours of
each LSD/placebo treatment session. They must agree not to use nicotine for at least 2
hours before and 6 hours after each dose of LSD. They must agree to not ingest
alcohol-containing beverages for at least 1 day before each LSD treatment session.
Non-routine medications for treating breakthrough pain taken in the 24 hours before
the LSD treatment session may result in rescheduling the treatment session to another
date, with the decision at the discretion of the investigators after discussion with
the participant.

10. Participants must be willing not to drive a traffic vehicle or to operate machines
within 24 h after LSD/placebo administration.

Exclusion Criteria:

1. Women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control (double-barrier method, i.e.
pill/intrauterine device and preservative/diaphragm).

2. Past or present diagnosis of a primary psychotic disorder. Subjects with a first
degree relative with psychotic disorders are also excluded.

3. Past or present bipolar disorder (DSM-IV)

4. Current substance use disorder (within the last 2 months, DSM-V, except nicotine)

5. Somatic disorders including central nervous system (CNS) involvement of the cancer,
severe cardiovascular disease, untreated hypertension, severe liver disease (liver
enzymes increase by more than 5 times the upper limit or normal) or severely impaired
renal function (estimated creatinine clearance <30 ml/min), or other that in the
judgement of the investigators pose too great potential for side effects

6. Weight < 45 kg

7. Suicide risk or likely to require psychiatric hospitalization during the course of the
study

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



Age minimum: 25 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Anxiety Disorders
Patients
Intervention(s)
Drug: LSD
Drug: Placebo
Primary Outcome(s)
Reduction in anxiety assessed by questionnaires [Time Frame: 16 weeks post-intervention]
Secondary Outcome(s)
Reduction in anxiety assessed by questionnaires [Time Frame: 2 and 8 weeks post-intervention]
Reduction in Depression assessed by questionnaires [Time Frame: 2, 8 and 16 weeks post-intervention]
Reduction of psychopathological symptoms assessed by questionnaires [Time Frame: 2, 8 and 16 weeks post-intervention]
Sustained Response assessed by questionnaires [Time Frame: 52 weeks post intervention]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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