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. 2023 Sep 18:14:1215972.
doi: 10.3389/fpsyt.2023.1215972. eCollection 2023.

Nature-themed video intervention may improve cardiovascular safety of psilocybin-assisted therapy for alcohol use disorder

Affiliations

Nature-themed video intervention may improve cardiovascular safety of psilocybin-assisted therapy for alcohol use disorder

Keith G Heinzerling et al. Front Psychiatry. .

Abstract

Introduction: Psychedelic-assisted therapy with psilocybin has shown promise in Phase 2 trials for alcohol use disorder (AUD). Set and setting, particularly factors facilitating a connection with nature, may positively influence the psychedelic experience and therapeutic outcomes. But to date, randomized controlled trials of interventions to enhance set and setting for psychedelic-assisted therapy are lacking.

Methods: This was a pilot randomized, controlled trial of Visual Healing, a nature-themed video intervention to optimize set and setting, versus Standard set and setting procedures with two open-label psilocybin 25 mg dosing sessions among 20 participants with AUD. For the first session, participants randomized to Visual Healing viewed nature-themed videos during the preparation session and the "ascent" and "descent" phases of the psilocybin dosing session while participants randomized to the Standard condition completed a meditation during the preparatory session and wore eyeshades and listened to a music playlist throughout the dosing session. For the second session 4 weeks later, participants chose either Visual Healing or Standard procedures. Primary outcomes were feasibility, safety, and tolerability of Visual Healing. Secondary and exploratory outcomes were changes in alcohol use, psychedelic effects, anxiety and stress.

Results: Nineteen of 20 (95%) randomized participants (mean age 49 ± 11 years, 60% female) completed the 14-week study. During the first psilocybin session, participants viewed an average of 37.9 min of the 42-min video and there were no video-related adverse events. Peak increase in post-psilocybin blood pressure was significantly less for participants randomly assigned to Visual Healing compared to Standard procedures. Alcohol use decreased significantly in both Visual Healing and Standard groups and psychedelic effects, stress, and anxiety were similar between groups.

Discussion: In this open-label pilot study, viewing Visual Healing videos during preparation and psilocybin dosing sessions was feasible, safe, and well-tolerated among participants with AUD. Preliminary findings suggest that Visual Healing has potential to reduce the cardiovascular risks of psychedelic therapy, without interfering with the psychedelic experience or alcohol-related treatment outcomes. Studies to replicate our findings as well as studies of different set and setting interventions with other psychedelic medications and indications are warranted.

Keywords: alcohol use disorder; nature therapy; psilocybin; psychedelic-assisted therapy; set and setting; video interventions.

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Conflict of interest statement

KH, DK, and LS are inventors for a provisional patent application by Pacific Neuroscience Institute Foundation for a video-based set and setting intervention. KH, KS, ML, and DK receive clinical trial support from Usona Institute. DK has stock in MindMed, Numinus, and Noetic Fund. KH is a consultant for MindMed. KS is a consultant for Field Trip Health and has stock in Compass Pathways, Field Trip Health, and MindMed. Author LS was employed by company Moving Art. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Overview of Visual Healing intervention versus Standard control procedures during the preparatory counseling and psilocybin dosing sessions. * Weeks 2 and 3 participants were randomly assigned to Visual Healing versus Standard procedures while Weeks 6 and 7 participants chose Visual Healing or Standard procedures.
Figure 2
Figure 2
CONSORT Diagram.
Figure 3
Figure 3
Mean drinking days and mean heavy drinking days per week for participants randomly assigned to the Visual Healing and Standard groups (Weeks −4 through −1: baseline/screening; Weeks 1–2: Preparatory/Alcohol counseling; Week 3 = psilocybin 25 mg plus Visual Healing or Standard procedures by random assignment; Weeks 4–6: Integration/Alcohol counseling; Week 7: psilocybin 25 mg plus Visual Healing or Standard procedures by participant choice; Weeks 8–10: Integration/Alcohol counseling; Weeks 10–14: Follow-up). * p < 0.05 for Weeks 1–2 versus baseline for drinking days and heavy drinking days in both Visual Healing and Standard, p < 0.05 for Weeks 4–7 versus Weeks 1–2 baseline for drinking days and heavy drinking days in both Visual Healing and Standard.
Figure 4
Figure 4
(A) Peak change in systolic (SBP) and diastolic blood pressure (DBP) and heart rate (HR) following 25 mg psilocybin administered during the Week 3 psilocybin session among participants randomly assigned to the Visual Healing (N = 10) versus Standard group (N = 10). *p < 0.05 for Visual Healing versus Standard. (B) Peak change in SBP, DBP, and HR following 25 mg psilocybin in Weeks 3 and 7 for individual participants in the Standard group who chose (N = 6) versus did not choose (N = 3) to view the Visual Healing video in Week 7.

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