Clinical TrialAnxiety DisordersLSDPlaceboCompleted

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

Double-blind, placebo-controlled randomized crossover (n=46) testing two single-dose LSD 200 µg sessions versus two placebo sessions in patients with anxiety with or without life-threatening illness.

Target Enrollment
46 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomized, double-blind, placebo-controlled crossover trial evaluated the efficacy of LSD for anxiety in patients with or without advanced life-threatening illness, building on earlier pilot work suggesting anxiolytic effects.

Participants received two single doses of LSD 200 µg and two matching placebo sessions in randomized order; subjects served as their own controls with outcomes assessed at 2, 8, and 16 weeks post-treatment.

Primary outcomes included reduction in anxiety (STAI); secondary measures included HDRS, BDI and SCL-90 to evaluate depressive and general psychopathological symptoms.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

LSD

experimental

Active arm: two single-dose LSD 200 µg sessions in a randomized crossover.

Interventions

  • LSD200 µg
    via Oral• two sessions• 2 doses total

    Two single 200 µg doses per participant (crossover design).

Placebo

inactive

Matching placebo capsules; two placebo sessions in crossover.

Interventions

  • Placebo
    via Oral• two sessions• 2 doses total

    Mannitol capsules visually identical to LSD; two sessions.

Participants

Ages
25 – 99
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment46 participants
  • Timeline
    Start: 2017-05-31
    End: 2021-05-01
  • Compounds
    LSDPlacebo
  • Topic
    Anxiety Disorders

Locations

University Hospital Basel — Basel, Canton of Basel-City, Switzerland
Private Practice P.Gasser — Solothurn, Canton of Solothurn, Switzerland

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