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| Sponsor: | Multidisciplinary Association for Psychedelic Studies |
|---|---|
| Information provided by: | Multidisciplinary Association for Psychedelic Studies |
| ClinicalTrials.gov Identifier: | NCT00920387 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety |
Drug: Lysergic acid diethylamide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Administering 200 mcg LSD once during each of two LSD-assisted psychotherapy sessions scheduled two to four weeks apart.
|
Drug: Lysergic acid diethylamide
Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session
|
|
2: Active Comparator
Participant will receive 20 mcg LSD once during two LSD-assisted psychotherapy sessions scheduled two to four weeks apart
|
Drug: Lysergic acid diethylamide
Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session
|
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter Gasser, MD | 032 622 40 20 | PGasser@gmx.net |
| Switzerland | |
| Private Practices of Peter Gasser MD | Recruiting |
| Solothurn, Switzerland | |
| Contact: Peter Gasser, MD 032 622 40 20 Pgasser@gmx.net | |
| Principal Investigator: Peter Gasser, MD | |
| Sub-Investigator: Barbara Speich, BSN | |
| Private Practices of Peter Gasser MD | Recruiting |
| Solothurn, Switzerland | |
| Contact: Peter Gasser, MD 032 622 40 20 Pgasser@gmx.net | |
| Principal Investigator: Peter Gasser, MD | |
| Sub-Investigator: Barbara Speich, PhD | |
| Principal Investigator: | Peter Gasser, MD | Private practices of Peter Gasser; Swiss Medical Association for Psycholytic Therapy (SAPT) |
More Information
| Responsible Party: | Multidisciplinary Association for Psychedelic Studies ( Rick Doblin; President ) |
| Study ID Numbers: | LDA1 |
| Study First Received: | June 12, 2009 |
| Last Updated: | June 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00920387 History of Changes |
| Health Authority: | Switzerland: Swissmedic; United States: Food and Drug Administration |
|
Anxiety quality of life psychotherapy potentially fatal illness lysergic acid diethylamide |
|
Lysergic Acid Diethylamide Serotonin Agonists Neurotransmitter Agents Serotonin Antagonists Serotonin Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs Hallucinogens Central Nervous System Agents Pharmacologic Actions |