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Three participants received benzodiazepines two experimental dose and one active placebo as needed. Three participants received pain medication during the study, only one of which was required as rescue medication for a treatment-emergent AE. Acetaminophen was required for this participant for a moderate headache the day after an experimental dose session.
Physiological measures were recorded for all participants during experimental sessions. Consistent with the previous findings Kornetsky, ; Sokoloff et al. All research with LSD -assisted psychotherapy in the s and the s came to a halt by the early s. Our study, the first in more than 40 years to evaluate safety and efficacy of LSD as an adjunct to psychotherapy, was conducted in participants with anxiety after being diagnosed with a life-threatening illness.
In contrast to the shortcomings of older studies, we used a controlled, randomized, and blinded study design to meet contemporary research standards.
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Congruent with studies in the past Hintzen and Passie, , the few mild somatic effects of LSD such as changes in heart rate and blood pressure were of no clinical significance. The primary outcome variable in this study was of the STAI anxiety measure. Patients with life-threatening illnesses confront an existential threat from shortened life expectancy that often causes periods of suffering, pain, and anxiety. Congruent with earlier studies Pahnke et al. Furthermore, the more stable personality-inherent feature of anxiety proneness trait anxiety showed a strong trend toward reduction.
Trait anxiety is not expected to be altered by short-term psychotherapy Spielberger et al. Therefore, this trait change may be supported by neurobiological effects of adjunctive use of LSD , which was originally introduced for deepening and accelerating psychotherapeutic processing Abramson, and, in some studies, was shown to alter personality traits MacLean et al. In this study, the experimental dose reduced anxiety when administered in either the blinded treatment or the open-label crossover for the active placebo subjects.
These results were stable over time as shown by the month follow-up. Eleven of 12 participants treated were LSD -naive. Most of the participants stated a preference for more than two LSD sessions and a longer treatment period. A longer treatment period with additional LSD sessions and larger doses may be indicated Gasser, As a pilot study, this study had limited sample size, which reduced precision in effect size estimates and significance testing.
The sample size selected was sufficient for a study primarily focused on safety and feasibility. The imperfect blinding also limits the validity of the results. The problem of the double blind in studies with pharmacologically active substances is a well-known methodological challenge Mogar, ; Salzman, LSD is a potent psychoactive drug, and participants and therapists are likely to detect whether an experimental dose or an inactive placebo or active placebo of very low dose of LSD was administered.
Although using a slightly higher LSD dose in the comparator group can increase blinding, it can also increase efficacy of the comparator, compromising the estimates of effect size. Other limitations exist in treating participants with grave somatic diseases because the course of the somatic illness e. The quality of life questionnaire EORTC-QLQ , which was chosen as a secondary outcome measure, focuses extensively on physical aspects and was insufficient for evaluating long-term psychological changes.
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Future studies should include a quality of life measure that focuses on psychological well-being more so than physical aspects of quality of life in this population. Group comparison results support positive trends in reduction of anxiety after two sessions of LSD -assisted psychotherapy, with effect size estimates in the range of 1. In view of promising historical studies with adjunctive LSD treatment in this population and a recent promising study using psilocybin Grob et al. The authors thank B. Speich, M. Jegerlehner, and K. Haenseler for study management and C.
Blank and K. Kirchner for study coordination. LSD ; psychedelic ; psycholytic therapy ; hallucinogen ; anxiety disorder. You may be trying to access this site from a secured browser on the server. Please enable scripts and reload this page. Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent.
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