Can pragmatic research, real-world data and digital technologies aid the development of psychedelic medicine?
Robin Carhart-Harris, Anne C Wagner, Manish Agrawal, Hannes Kettner, Jerold F Rosenbaum, Adam Gazzaley, David Nutt, David Erritzøe
Journal of Psychopharmacology April 22, 2021 DOI: 10.1177/02698811211008567 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Psychedelic medicine Innovative treatments Psychopharmacology Psychedelic research Real-world evidence Real-world data Pragmatic research Patient experiences Everyday settings Observational studies Rwe Digital health Digital technologies Apps Mhealth Ehealth Digital therapeutics Healthcare integration Advancing treatments Treatment integration Medical innovation Healthcare innovation Healthcare system |
| Citations | 54 |
| Key points | Proposes that supplementing traditional confirmatory trials with pragmatic trials, real-world data initiatives, and digital health solutions can better support the discovery of optimal and personalized psychedelic therapy protocols. |
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.
Comparable studies
Other theoretical and historical papers on psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Theorizing that Psychedelic Assisted Therapy May Play a Role in the Treatment of Trauma-Induced Personality Disorders. | 2024 | Theoretical or philosophical paper | |
| Learning to Let Go: A Cognitive-Behavioral Model of How Psychedelic Therapy Promotes Acceptance | 2020 | Theoretical or philosophical paper | |
| Awe: a putative mechanism underlying the effects of classic psychedelic-assisted psychotherapy | 2018 | Theoretical or philosophical paper | |
| Ethical and legal issues in psychedelic harm reduction and integration therapy | 2021 | Theoretical or philosophical paper | |
| Towards psychedelic apprenticeship: Developing a gentle touch for the mediation and validation of psychedelic-induced insights and revelations. | 2022 | Theoretical or philosophical paper |
Citations in the library
Cited by 50
- Increased global integration in the brain after psilocybin therapy for depression. Nature Medicine April 11, 2022
- Therapeutic Alliance and Rapport Modulate Responses to Psilocybin Assisted Therapy for Depression Frontiers in Pharmacology March 31, 2022
- Great Expectations: recommendations for improving the methodological rigor of psychedelic clinical trials Psychopharmacology April 1, 2022
- Psychedelic Communitas: Intersubjective Experience During Psychedelic Group Sessions Predicts Enduring Changes in Psychological Wellbeing and Social Connectedness. Frontiers in Pharmacology March 25, 2021
- Psychedelic therapy in the treatment of addiction: the past, present and future Frontiers in Psychiatry June 12, 2023
and 45 more in the library
Cites 25
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Journal of Psychopharmacology November 30, 2016
- Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- REBUS and the Anarchic Brain: Toward a Unified Model of the Brain Action of Psychedelics Pharmacological Reviews June 20, 2019
and 20 more in the library