Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?
Robin L Carhart-Harris, Anne C Wagner, Manish Agrawal, Hannes Kettner, Jerold F Rosenbaum, Adam Gazzaley, David J Nutt, David Erritzøe
J Psychopharmacol April 22, 2021 DOI: 10.1177/02698811211008567 via PubMed Central
Summary
AI-generated from the abstractPsychedelic therapy is experiencing a resurgence due to favorable regulations, policy changes, and positive trial results, but current confirmatory trials may not fully address safety and best practice. The authors recommend supplementing these trials with pragmatic trials, real-world data initiatives, and digital health solutions to discover optimal and personalized treatment protocols. These steps aim to develop safe, effective, and cost-efficient psychedelic therapy, which is susceptible to hype and regulatory challenges given its history.
Study at a glance
| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Psychedelic medicine Innovative treatments Psychopharmacology Psychedelic research |
| Citations | 54 |
| Key finding | Supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives, and digital health solutions can better support the discovery of optimal and personalized treatment protocols for psychedelic therapy. |
Abstract
Favourable regulatory assessments, liberal policy changes, new research centres and substantial commercial investment signal that psychedelic therapy is making a major comeback. Positive findings from modern trials are catalysing developments, but it is questionable whether current confirmatory trials are sufficient for advancing our understanding of safety and best practice. Here we suggest supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives and digital health solutions to better support the discovery of optimal and personalised treatment protocols and parameters. These recommendations are intended to help support the development of safe, effective and cost-efficient psychedelic therapy, which, given its history, is vulnerable to excesses of hype and regulation.