Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases

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.

Trial registration: ClinicalTrials.gov NCT00920387.

FIGURE 1

Consolidated standards of reporting trials LSD/anxiety flow diagram.

FIGURE 2

Study outcomes. State and trait anxiety scores in the LSD and placebo group. Values are mean ± SEM of changes from baseline in eight subjects in the LSD group and three subjects in the placebo group. Measures were obtained before the first treatment session (baseline), 1 week after the first treatment (post 1 LSD), 1 week after the second treatment (LSD 2), and at follow-up after 2 months. At 2 months, state anxiety scores were significantly lower in the LSD group compared with the placebo group. The crossover group (n = 3) shows a positive trend of STAI state and trait score reduction. At 12-month follow-up, the state and trait values remain stable compared with the 2-month follow-up.