Clinical trial NCT00920387
Conditions: Anxiety
Keywords: Anxiety quality of life psychotherapy potentially fatal illness lysergic acid diethylamide
Sponsor: Multidisciplinary Association for Psychedelic Studies
Start date: 2008-02-01; Completion date: 2012-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 200 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart. arm 2: 20 mcg LSD administered once during each of two LSD-assisted therapy sessions, scheduled two to four weeks apart.
Interventions: intervention 1: 200 mcg LSD intervention 2: 20 mcg LSD intervention 3: Therapy
Intervention descriptions: intervention 1: Administering 200 mcg LSD orally once at the start of each of two day-long psychotherapy session intervention 2: Administer 20 mcg LSD orally once at the start of each of two day-long psychotherapy session intervention 3: Therapy provided by male and female co-therapists

Protocol documents: