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

NCT00920387 | Completed Phase 2 Results

• 1 other identifier: LDA1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; quality of life; psychotherapy; potentially fatal illness; lysergic acid diethylamide

Outcome Measures

Primary Outcomes (2)

• Baseline State-Trait Anxiety Inventory (STAI)

  The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The STAI-state subscale is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Participants respond to each item by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"). STAI-state scores are summed for a total score that range from 20 to 80, with higher scores indicating greater state anxiety. The STAI-trait subscale also consists of 20-items and is scored the same way, with total scores ranging from 20 to 80, with higher scores indicating greater trait anxiety.

  Baseline (Visit 4)

• Primary Endpoint State-Trait Anxiety Inventory (STAI)

  The STAI differentiates between State Anxiety, defined as "anxiety experienced in reaction to a specific environmental circumstance," and Trait Anxiety, defined as "long-standing nervous affect or anxiety disorder." The STAI-state subscale is a 20-item self-reported scale which assesses subjects' levels of transient, situationally oriented, anxiety. Participants respond to each item by selecting a response from a 4-point Likert scale ranging from 4 ("Not at all") to 1 ("Very much so"). STAI-state scores are summed for a total score that range from 20 to 80, with higher scores indicating greater state anxiety. The STAI-trait subscale also consists of 20-items and is scored the same way, with total scores ranging from 20 to 80, with higher scores indicating greater trait anxiety.

  2 months after second experimental session

Study Arms (2)

Full Dose LSD (200 mcg)

EXPERIMENTAL

200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

Drug: 200 mcg LSD; Behavioral: Therapy

Active Placebo LSD (20 mcg)

ACTIVE COMPARATOR

20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.

Drug: 20 mcg LSD; Behavioral: Therapy

Interventions

200 mcg LSD DRUG

Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session

Also known as: Lysergic acid diethylamide

Full Dose LSD (200 mcg)

20 mcg LSD DRUG

Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session

Also known as: Lysergic acid diethylamide

Active Placebo LSD (20 mcg)

Therapy BEHAVIORAL

Therapy provided by male and female co-therapists

Active Placebo LSD (20 mcg); Full Dose LSD (200 mcg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multidisciplinary Association for Psychedelic Studies: lead

Study Sites (1)

Private Practices of Peter Gasser MD

Solothurn, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24594678 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Lysergic Acid Diethylamide; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Berra Yazar-Klosinski, PhD / Chief Scientific Officer
• Organization: Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corp.

trialdata@mapsbcorp.com

(831) 429-6362

Study Officials

• Peter Gasser, MD

  Private practices of Peter Gasser; Swiss Medical Association for Psycholytic Therapy (SAPT)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: February 1, 2008
• Primary Completion: April 14, 2011
• Study Completion: September 1, 2012
• Last Updated: July 12, 2023
• Results First Posted: December 8, 2021

Record last verified: 2023-07

Locations

CH (1)