Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings
This safety-feasibility trial (n=2) explored the interaction between psilocybin and buprenorphine in adults with opioid use disorder (OUD). The study found that coadministration of psilocybin and buprenorphine was safely tolerated, with no serious adverse events or significant changes in opioid craving or withdrawal measures. Feasibility challenges led to modifications in the study population and eligibility criteria, emphasizing the need for improved accessibility and overall generalizability.
Authors
- Christopher Nicholas
- Paul Hutson
Published
Abstract
Background
Psilocybin has demonstrated promising clinical outcomes for nicotine and alcohol use disorders, yet its potential clinical utility in the treatment of opioid use disorder (OUD) remains unreported in modern literature. This technical report presents methodological considerations and preliminary data from a safety-feasibility trial examining the interaction between psilocybin and buprenorphine in two adults diagnosed with OUD.
Procedures
Two adults meeting eligibility criteria for long-term stabilization of buprenorphine/naloxone (≥6 months) enrolled and underwent two psilocybin dosing sessions in a supportive setting. Preliminary data pertaining to the safety, clinical outcomes, and subjective effects of psilocybin were collected.Main Findings: Two participants received psilocybin and completed all study visits. Feasibility considerations were identified, including limitations in provider-based recruitment strategies, participant accessibility, flexibility of the study schedule, and initial eligibility criteria. There were no serious adverse events or significant baseline changes on measures of opioid craving or withdrawal, and the subjective effects associated with psilocybin were consistent with previous studies.Principal Conclusions: 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.
Research Summary of 'Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings'
Introduction
Opioid use disorder (OUD) remains a major public health problem in the United States despite established medications for OUD (MOUD) such as methadone and buprenorphine, which reduce mortality and improve retention. Previous trials of psilocybin-assisted therapy (PAT) have shown preliminary efficacy and acceptable safety for several mental health conditions and for substance use disorders such as alcohol and nicotine use disorders. However, modern clinical data on psilocybin for OUD are lacking, although earlier population-based and historical LSD work suggest potential relevance. Proposed therapeutic mechanisms for PAT that could apply to OUD include increases in psychological flexibility, mindfulness, motivation, prosociality, and experiences described as mystical or awe-related, possibly mediated by neuroplasticity and changes in predictive models of addiction-related cognition and behaviour. Nicholas and colleagues reported a technical safety–feasibility study that aimed to evaluate coadministration of psilocybin with buprenorphine in adults stabilised on buprenorphine/naloxone. The report focuses on study design decisions, logistical and safety considerations, and preliminary outcomes from the first two enrolled participants, to inform future trials and methodology for evaluating psilocybin in outpatient, community-based OUD populations.
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Study Details
- Study Typeindividual
- Journal
- Compound
- Topics
- Authors
- APA Citation
Nicholas, C. R., Horton, D. M., Malicki, J., Baltes, A., Hutson, P. R., & Brown, R. T. (2023). Psilocybin for Opioid Use Disorder in Two Adults Stabilized on Buprenorphine: A Technical Report on Study Modifications and Preliminary Findings. Psychedelic Medicine, 1(4), 253-261. https://doi.org/10.1089/psymed.2023.0012
References (33)
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Horton, D. M., Morrison, B., Schmidt, J. · American Journal of Psychotherapy (2021)
Bogenschutz, M. P., Forcehimes, A. A., Pommy, J. A. et al. · Journal of Psychopharmacology (2015)
Bogenschutz, M. P., Ross, S., Bhatt, S. R. et al. · JAMA Psychiatry (2022)
Johnson, M. W., Garcia-Romeu, A., Cosimano, M. P. et al. · Journal of Psychopharmacology (2014)
Johnson, M. W., Garcia-Romeu, A., Griffiths, R. R. · The American Journal of Drug and Alcohol Abuse (2016)
Pisano, V. D., Putnam, N. P., Kramer, H. M. et al. · Journal of Psychopharmacology (2017)
Jones, G. M., Ricard, J. A., Lipson, J. et al. · Scientific Reports (2022)
Garcia-Romeu, A., Davis, A. K., Griffiths, R. R. et al. · Frontiers in Psychiatry (2020)
Doss, M. K., Považan, M., Rosenberg, M. D. et al. · Translational Psychiatry (2021)
Heuschkel, K., Kuypers, K. P. C. · Frontiers in Psychiatry (2020)
Show all 33 referencesShow fewer
Teixeira, P. J., Johnson, M. W., Timmermann, C. et al. · Journal of Psychopharmacology (2021)
Hendricks, P. S. · International Review of Psychiatry (2018)
Garcia-Romeu, A., Griffiths, R. R., Johnson, M. W. · Current Drug Abuse Reviews (2015)
Kraehenmann, R., Preller, K. H., Scheidegger, M. et al. · Biological Psychiatry (2015)
Watts, R., Day, C. M., Krzanowski, J. et al. · Journal of Humanistic Psychology (2017)
Shao, L-X,, Liao, C., Gregg, I. et al. · Neuron (2021)
Skosnik, P. D., Sloshower, J., Safi-Aghdam, H. et al. · Journal of Psychopharmacology (2023)
Kočárová, C., Horacek, J., Carhart-Harris, R. L. · Frontiers in Psychiatry (2021)
Ly, C., Greb, A. C., Cameron, L. P. et al. · Cell Reports (2018)
Carhart-Harris, R. L., Friston, K. J. · Pharmacological Reviews (2019)
Johnson, M. W., Richards, W. A., Griffiths, R. R. · Journal of Psychopharmacology (2008)
Hartogsohn, I. · Journal of Psychopharmacology (2016)
Timmermann, C., Watts, R., Dupuis, D. · Transcultural Psychiatry (2022)
Brown, R. T., Nicholas, C. R., Cozzi, N. V. et al. · Clinical Pharmacokinetics (2017)
Nicholas, C. R., Henriquez, K. M., Gassman, M. C. et al. · Journal of Psychopharmacology (2018)
Johnson, M. W., Sewell, R. A., Griffiths, R. R. · Drug and Alcohol Dependence (2012)
Carhart-Harris, R. L., Bolstridge, M., Rucker, J. et al. · Lancet Psychiatry (2016)
Griffiths, R. R., Johnson, M. W. · Journal of Psychopharmacology (2016)
Griffiths, R. R., Johnson, M. W., Richards, W. A. et al. · Psychopharmacology (2011)
Knight, G., Rucker, J., Cleare, A. J. et al. · Frontiers in Psychiatry (2022)
Hirschfeld, T., Schmidt, T. T. · Journal of Psychopharmacology (2021)
Studerus, E., Kometer, M., Hasler, F. et al. · Journal of Psychopharmacology (2010)
Carhart-Harris, R. L., Giribaldi, B., Watts, R. et al. · New England Journal of Medicine (2021)
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