Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings
Julia Malicki, Amelia Baltes, Christopher R. Nicholas, David Horton, Paul R. Hutson, Randall Brown
Psychedelic Medicine December 1, 2023 DOI: 10.1089/psymed.2023.0012 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical trial Peer reviewed |
|---|---|
| Population | People with opioid use disorder |
| Interventions | Psilocybin Buprenorphine |
| Topics | Addiction Psilocybin |
| Keywords | Buprenorphine Hallucinogen Psychotherapist Pharmacology |
| Citations | 7 |
| Registration | NCT05242029 |
| Key findings | Coadministration of psilocybin and buprenorphine was safely tolerated and did not show contraindicating effects on buprenorphine's effectiveness or psilocybin's subjective effects. |
Abstract
Coadministration of psilocybin and buprenorphine was safely tolerated and did not demonstrate contraindicating effects vis-à-vis effectiveness of buprenorphine or the subjective effects of psilocybin. Challenges in feasibility led to modifications in the sample population and eligibility criteria and strategies to improve accessibility, minimize burden, and enhance overall generalizability.clinicaltrials.gov ID: NCT05242029.
Comparable studies
Other non-randomized and open-label trials on psilocybin for addiction, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction Psychiatrically healthy nicotine-dependent smokers | 2014 | Open-label pilot study | n = 15 |
| Psilocybin-Occasioned Mystical Experiences in the Treatment of Tobacco Addiction Smokers | 2015 | Open-label pilot study | n = 15 |
| The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions Participants in a psilocybin-assisted treatment study for alcohol dependence | 2018 | Open-label pilot (proof-of-concept) study with qualitative content analysis | n = 17 |
| It’s time to take psilocybin seriously as a possible treatment for substance use disorders | 2016 | Pilot study | |
| Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study Treatment-seeking adults with severe alcohol use disorder | 2025 | Open-label, single-group study | n = 10 |
Citations in the library
Cited by 9
- Sex-specific role of the 5-HT2A receptor in psilocybin-induced extinction of opioid reward. Nature Communications November 20, 2025
- From taboo to treatment: The emergence of psychedelics in the management of pain and opioid use disorder. British Journal of Clinical Pharmacology December 1, 2024
- Psychedelics and chronic pain: self-reported outcomes on changed substance use patterns and health following naturalistic psychedelic use British Journal of Pain February 11, 2025
- The therapeutic effects of psychedelics for opioid use disorder: A systematic review of clinical studies. Psychiatry Research June 1, 2025
- Therapeutic Potential of Psychedelic Compounds for Substance Use Disorders. Pharmaceuticals November 5, 2024
and 4 more in the library
Cites 38
- 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
- Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology July 1, 2008
- Psilocybin-assisted treatment for alcohol dependence: A proof-of-concept study Journal of Psychopharmacology January 13, 2015
and 33 more in the library