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Safety and Efficacy of Lysergic Acid Diethylamide-Assisted Psychotherapy for Anxiety Associated With Life-threatening Diseases

Peter Gasser, Dominique Holstein, Yvonne Michel, Rick Doblin, Berra Yazar-Klosinski, Torsten Passie, Rudolf Brenneisen

The Journal of Nervous and Mental Disease March 4, 2014 DOI: 10.1097/nmd.0000000000000113 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Placebo-controlled Double-blind Open-label Peer reviewed
Sample size 12
Population Patients with anxiety associated with life-threatening diseases
Intervention LSD-assisted psychotherapy
Dose 200 μg of LSD
Duration 2-month follow-up, with sustained effects at 12 months
Topics Anxiety LSD Psychedelic-assisted therapy
Keywords Adverse effect Crossover study Placebo Trait anxiety Randomized controlled trial Psychotherapist Double blind Clinical psychology
Citations 752
Key findings LSD-assisted psychotherapy reduced trait and state anxiety at 2 months, with effects sustained for 12 months, and no serious adverse events.

Abstract

A double-blind, randomized, active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases. Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart. The participants received either 200 μg of LSD (n = 8) or 20 μg of LSD with an open-label crossover to 200 μg of LSD after the initial blinded treatment was unmasked (n = 4). At the 2-month follow-up, positive trends were found via the State-Trait Anxiety Inventory (STAI) in reductions in trait anxiety (p = 0.033) with an effect size of 1.1, and state anxiety was significantly reduced (p = 0.021) with an effect size of 1.2, with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events. STAI reductions were sustained for 12 months. These results indicate that when administered safely in a methodologically rigorous medically supervised psychotherapeutic setting, LSD can reduce anxiety, suggesting that larger controlled studies are warranted.

In the evidence

This study is part of the evidence base for 4 syntheses in the library. Here is how each one recorded it.

  • LSD-assisted psychotherapy reduced trait and state anxiety at 2 months, with effects sustained for 12 months, and no serious adverse events.

    Synthesized

  • LSD-assisted psychotherapy reduced trait and state anxiety at 2 months with large effect sizes, and reductions were sustained for 12 months with no serious adverse events.

    Synthesized

  • LSD-assisted psychotherapy significantly reduced trait and state anxiety at 2 months, with effects sustained for 12 months and no serious adverse events.

    Synthesized

  • LSD-assisted psychotherapy reduced trait and state anxiety at 2 months with effect sizes of 1.1 and 1.2, and reductions were sustained for 12 months with no serious adverse events.

    Synthesized

Comparable studies

Other randomized controlled trials on LSD and psychedelic-assisted therapy, most cited first.

Study Year Design Participants
LSD-assisted therapy in patients with anxiety: open-label prospective 12-month follow-up. Patients with anxiety with or without life-threatening illness 2024 Randomized controlled trial n = 39
Efficacy and safety of low- versus high-dose-LSD-assisted therapy in patients with major depression: A randomized trial. Patients with moderate-to-severe major depressive disorder 2025 Randomized controlled trial n = 61
PAM trial protocol: a randomised feasibility study of psychedelic microdosing-assisted meaning-centred psychotherapy in advanced stage cancer patients. Māori and non-Māori adults with advanced-stage cancer and symptoms of anxiety and/or... 2024 Randomized controlled trial protocol n = 40

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