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Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial.

Akash Goel·Calvin Diep·Ahnaf Zahin·Joshua D Rosenblat·Sérgio M Pereira·Bijan Teja·Kruthi Rao·Cheryl Pritlove·Kathryn Hodwitz·Hance Clarke·Joel Katz·Duminda N Wijeysundera·Janneth Pazmino-Canizares·Gabriella Mattina·Roshni Nayar·Zaaria Thomas·Kevin Dang·Karim S Ladha·Paul Ritvo·KARE Collaborators
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Abstract

BACKGROUND: Intravenous ketamine can provide short-term analgesia in chronic neuropathic pain but benefits often wane after treatment. We conducted a randomized pilot trial to assess the feasibility of combining ketamine infusions with psychotherapy to inform future efficacy trials. METHODS: In this single-center, randomized, outcome-assessor-blinded pilot trial at a Canadian tertiary pain clinic, adults with moderate-to-severe chronic neuropathic pain were randomly assigned in 1:1:1 ratio to the ketamine, psychotherapy, or combined ketamine plus psychotherapy arm. Ketamine was delivered as three intravenous infusions over 16 weeks; psychotherapy consisted of 16 weekly cognitive behavioral therapy and mindfulness-based meditation sessions. The primary outcome was feasibility, assessed using prespecified progression criteria. Exploratory outcomes included changes in pain interference (PROMIS 6a T-score), pain intensity, mood, and qualitative interview findings at week 20 (ClinicalTrials.gov: NCT05639322). FINDINGS: Between October 23, 2023, and March 31, 2025, 30 participants were randomized, and 26 (87%) completed 20-week follow-up. Most feasibility criteria, including consent, retention, data completeness, and absence of study-related serious adverse events, were met; adherence targets were partially met. Exploratory pain outcomes showed numerical improvement across groups, with clinically meaningful reductions observed for pain interference and pain intensity. Sixty-four adverse events were recorded, mostly mild and in ketamine-containing groups; no serious study-related adverse events occurred. CONCLUSIONS: Combined ketamine and psychotherapy was feasible and acceptably safe in this pilot trial, supporting evaluation in a larger efficacy-powered study. FUNDING: The study was funded by the St. Michael's Hospital Innovation Fund, The Canadian Pain Society Early Investigator Award and the Physician Services Incorporation Early Career Researcher Award.

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HumansKetaminePilot ProjectsNeuralgiaChronic PainMaleMiddle AgedFemaleAnalgesicsAdultCombined Modality TherapyFeasibility StudiesTreatment OutcomeCognitive Behavioral TherapyMindfulnessPain MeasurementInfusions, IntravenousPsychotherapyCanadaPROMIS Pain InterferencePatient Global Impression of Change Scalechronic neuropathic paincognitive behavioral therapyfeasibility outcomesintervention adherenceintravenous ketamineketamine-assisted psychotherapymindfulnessmixed-methodspain intensityqualitative interviewsrandomized pilot trialsafetytertiary pain clinictranslation to patientsJournal ArticleRandomized Controlled Trial

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Akash Goel, Calvin Diep, Ahnaf Zahin, Joshua D Rosenblat, Sérgio M Pereira, Bijan Teja, Kruthi Rao, Cheryl Pritlove, Kathryn Hodwitz, Hance Clarke, Joel Katz, Duminda N Wijeysundera, Janneth Pazmino-Canizares, Gabriella Mattina, Roshni Nayar, Zaaria Thomas, Kevin Dang, Karim S Ladha, Paul Ritvo, KARE Collaborators. 2026-08-13. Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial.. https://doi.org/10.1016/j.medj.2026.101259

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Journal Article; Randomized Controlled Trial resourceAdult subjectAnalgesics subjectCognitive Behavioral Therapy subjectCombined Modality Therapy subjectFeasibility Studies subjectFemale subjectHumans subjectInfusions, Intravenous subjectJournal Article subjectKetamine subjectMale subjectMiddle Aged subjectPain Measurement subjectPilot Projects subjectRandomized controlled trials study

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