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Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety

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ClinicalTrials.gov Identifier: NCT00920387
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):
Multidisciplinary Association for Psychedelic Studies

Tracking Information
First Submitted Date  ICMJE June 12, 2009
First Posted Date  ICMJE June 15, 2009
Last Update Posted Date May 7, 2014
Study Start Date  ICMJE February 2008
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2010)
Spielberger State-Trait Inventory (STAI) [ 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 ]
Self-report measure of trait and current anxiety
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [ Time Frame: Baseline, experimental session 1, non-drug psychotherapy between experimental session 1 and 2, experimental session 2, psychotherapy session 1 wk after experimental session, two months after second experimental session ]
  • Spielberger State-Trait Inventory (STAI) [ 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2010)
  • Hospital Anxiety and Depression Scale (HADS) [ 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 ]
    Self-report measure of anxiety and depression symptoms
  • Daily visual analog pain scale (VAPS) [ Time Frame: Once daily from baseline to two months after second experimental session ]
    Visual analog scale assessing levels of pain
  • Daily Anxiety/Pain Medication Diary [ Time Frame: Once daily from baseline to two months after second experimental session ]
    Visual analog measure of medication use
  • Symptom Checklist 90 [ Time Frame: Baseline, experimental session 1, non-drug psychotherapy between experimental session 1 and 2, experimental session 2, psychotherapy session 1 wk after experimental session, two months after second experimental session ]
    Self-report measure, assesses self-reported psychological symptoms (as anxiety, obsession-compulsion) and has global scales as well
  • European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire [ Time Frame: Baseline, experimental session 1, non-drug psychotherapy between experimental session 1 and 2, experimental session 2, psychotherapy session 1 wk after experimental session, two months after second experimental session ]
    Self-report measure of quality of life especially in relation to illness
Original Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2009)
  • Hospital Anxiety and Depression Scale (HADS) [ 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 ]
  • Daily visual analog pain scale (VAPS) [ Time Frame: Once daily from baseline to two months after second experimental session ]
  • Daily Anxiety/Pain Medication Diary [ Time Frame: Once daily from baseline to two months after second experimental session ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety
Official Title  ICMJE 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
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Drug: Experimental 200 mcg Lysergic acid diethylamide
    Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session
    Other Name: Lysergic acid diethylamide
  • Drug: Active Comparator 20 mcg lysergic acid diethylamide
    Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session
    Other Name: Lysergic acid diethylamide
  • Behavioral: Psychotherapy
    Psychotherapy provided by a male and a female psychotherapist
Study Arms  ICMJE
  • Experimental: Experimental 200 mcg lysergic acid diethylamide
    Administering 200 mcg LSD once during each of two LSD-assisted psychotherapy sessions scheduled two to four weeks apart.
    Interventions:
    • Drug: Experimental 200 mcg Lysergic acid diethylamide
    • Behavioral: Psychotherapy
  • Active Comparator: Active Comparator 20 mcg Lysergic acid diethylamide
    Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session
    Interventions:
    • Drug: Active Comparator 20 mcg lysergic acid diethylamide
    • Behavioral: Psychotherapy
Publications * Gasser P, Holstein D, Michel Y, Doblin R, Yazar-Klosinski B, Passie T, Brenneisen R. Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. J Nerv Ment Dis. 2014 Jul;202(7):513-20. doi: 10.1097/NMD.0000000000000113.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920387
Other Study ID Numbers  ICMJE LDA1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Multidisciplinary Association for Psychedelic Studies
Study Sponsor  ICMJE Multidisciplinary Association for Psychedelic Studies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Gasser, MD Private practices of Peter Gasser; Swiss Medical Association for Psycholytic Therapy (SAPT)
PRS Account Multidisciplinary Association for Psychedelic Studies
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP