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PatientsPhase 2LSD-assistNCT03153579

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders

A Phase 2 study testing LSD in people with Patients and Anxiety Disorders, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Patients, Anxiety Disorders
What is being tested?
LSD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
2 sitesSwitzerland
Study dates
23 Jun 2017to 15 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 25 years.
  • 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.
  • 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.
  • Patients without advanced-stage potentially fatal illness need to meet DSM-IV criteria for anxiety disorder (elevated STAI score not sufficient for inclusion)
  • Sufficient understanding of the study procedures and risks associated with the study.
  • Participants must be willing to adhere to the study procedures and sign the consent form.
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  • 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]).
  • 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).
  • 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.
  • Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD/placebo administration.

Who cannot join

  • 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).
  • Past or present diagnosis of a primary psychotic disorder. Subjects with a first degree relative with psychotic disorders are also excluded.
  • Past or present bipolar disorder (DSM-IV)
  • Current substance use disorder (within the last 2 months, DSM-V, except nicotine)
  • 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
  • Weight < 45 kg
  • Suicide risk or likely to require psychiatric hospitalization during the course of the study
  • 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.

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • University Hospital Basel

    Basel, Canton of Basel-City, 4056

  • Private Practice P.Gasser

    Solothurn, Canton of Solothurn, 4500

Other trials in Switzerland

About this study

Official 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

Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in experimental studies in healthy subjects and in the treatment for anxiety in patients with life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies are warranted. Similar studies have recently been completed with the hallucinogen psilocybin.

Objective: To test the efficacy of LSD in patients with anxiety with or without life-threatening diseases.

Read more

Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg) and two placebo sessions with subjects acting as their own control.

Participants: 40 patients aged > 25 years with anxiety disorder (according to DSM-IV or a state-trait anxiety inventory score >40 in the STAI trait or state scale) with or without life-threatening illness.

Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with placebo-assisted psychotherapy.

Significance: Anxiety disorder (alone or in the context of life-threatening illness) is frequent and often insufficiently managed with available medications. This study will evaluate the potential benefits of single treatments with LSD in anxiety disorder.

Being tested
LSD, Placebo
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LSDDrug

    Lysergic Acid Diethylamide

    200ug per os, single dose

  • PlaceboDrug

    Capsules containing mannitol looking identical to LSD

Study groups in NCT03153579
Study groupRoleWhat they receive
Placebo, LSDOtherCross-over within-subjects design with all treatment conditions, arms starting with either Placebo or lysergic acid diethylamide (LSD)
Receives: Drug: Placebo
LSD, PlaceboOtherCross-over within-subjects design with all treatment conditions, arms starting with either Placebo or lysergic acid diethylamide (LSD)
Receives: Drug: LSD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in anxiety assessed by questionnaires

    Reduction in anxiety assessed by questionnaires (STAI) 16 weeks after LSD compared with placebo

    Measured: 16 weeks post-intervention

Secondary outcomes (4)

  1. Reduction in Depression assessed by questionnaires

    Reduction in depression will be assessed by questionnaires (HDRS, BDI) 2, 8 and 16 weeks after LSD compared with placebo

    Measured: 2, 8 and 16 weeks post-intervention

  2. Reduction in anxiety assessed by questionnaires

    Reduction in anxiety will be assessed by questionnaire (STAI) 2 and 8 weeks after LSD compared with placebo

    Measured: 2 and 8 weeks post-intervention

  3. Reduction of psychopathological symptoms assessed by questionnaires

    Reduction of psychopathological symptoms will be assessed by questionnaire (SCL-90) 2, 8, and 16 weeks after LSD compared with placebo

    Measured: 2, 8 and 16 weeks post-intervention

  4. Sustained Response assessed by questionnaires

    Follow-up using different questionnaires to compare (within-subject) the 52-week response with Responses from baseline and 16-weeks.

    Measured: 52 weeks post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start23 Jun 2017
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
randomized, double-blind, placebo-controlled, crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03153579
Sponsor's protocol ID
BASEC 2016-00992
Acronym
LSD-assist
Status last verified
Dec 2021
First submitted
9 May 2017
Last updated
22 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Holze F, Gasser P, Muller F, Dolder PC, Liechti ME. Lysergic Acid Diethylamide-Assisted Therapy in Patients With Anxiety With and Without a Life-Threatening Illness: A Randomized, Double-Blind, Placebo-Controlled Phase II Study. Biol Psychiatry. 2023 Feb 1;93(3):215-223. doi: 10.1016/j.biopsych.2022.08.025. Epub 2022 Sep 5.

    PubMed 36266118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LSD in people with Patients and Anxiety Disorders, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in anxiety assessed by questionnaires (time frame: 16 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03153579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.

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