Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Intervention: 200 mcg LSD; 20 mcg LSD; Therapy
Intervention description: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session; Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session; Therapy provided by male and female co-therapists
Intervention MeSH terms: Lysergic Acid Diethylamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anxiety; quality of life; psychotherapy; potentially fatal illness; lysergic acid diethylamide

Summary:

      This study will find out whether psychotherapy combined with lysergic acid diethylamide (LSD)
      is safe and is helpful in people who are anxious because they have a potentially fatal
      disease. The study will measure anxiety and quality of life before and after people have two
      sessions with either full or active placebo dose of LSD. They expect LSD-assisted
      psychotherapy to reduce anxiety and improve quality of life.
    

Eligibility criteria:

        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
             medications.

          -  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.