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

IF 13.3 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

Med Pub Date : 2026-09-11 Epub Date: 2026-08-13 DOI:10.1016/j.medj.2026.101259

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

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引用次数: 0

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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氯胺酮辅助心理治疗减轻慢性神经性疼痛：一项混合方法随机试验。

背景：静脉注射氯胺酮可为慢性神经性疼痛提供短期镇痛，但治疗后效果往往减弱。我们进行了一项随机试验，以评估氯胺酮输注与心理治疗相结合的可行性，为未来的疗效试验提供信息。方法：在加拿大三级疼痛诊所进行的单中心、随机、结果评估盲试验中，患有中度至重度慢性神经性疼痛的成年人按1:1:1的比例随机分配到氯胺酮、心理治疗或氯胺酮加心理治疗组。氯胺酮在16周内静脉输注3次；心理治疗包括每周16次的认知行为治疗和以正念为基础的冥想。主要结局是可行性，使用预先规定的进展标准进行评估。探索性结果包括疼痛干扰（PROMIS 6a t评分）、疼痛强度、情绪和第20周定性访谈结果的变化（ClinicalTrials.gov: NCT05639322）。研究结果：在2023年10月23日至2025年3月31日期间，30名参与者被随机分组，26名（87%）完成了为期20周的随访。大多数可行性标准，包括同意、保留、数据完整性和无研究相关的严重不良事件，均得到满足；依从性指标部分达到。探索性疼痛结果显示各组间的数值改善，疼痛干扰和疼痛强度均有临床意义的减少。记录了64例不良事件，多数为轻度，且发生在含氯胺酮组；未发生与研究相关的严重不良事件。结论：氯胺酮联合心理治疗在该试点试验中是可行且安全的，支持在更大的疗效研究中进行评估。资助：该研究由圣迈克尔医院创新基金、加拿大疼痛协会早期研究者奖和医生服务公司早期职业研究者奖资助。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Med MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

17.70

自引率

0.60%

发文量

102

期刊介绍： Med is a flagship medical journal published monthly by Cell Press, the global publisher of trusted and authoritative science journals including Cell, Cancer Cell, and Cell Reports Medicine. Our mission is to advance clinical research and practice by providing a communication forum for the publication of clinical trial results, innovative observations from longitudinal cohorts, and pioneering discoveries about disease mechanisms. The journal also encourages thought-leadership discussions among biomedical researchers, physicians, and other health scientists and stakeholders. Our goal is to improve health worldwide sustainably and ethically. Med publishes rigorously vetted original research and cutting-edge review and perspective articles on critical health issues globally and regionally. Our research section covers clinical case reports, first-in-human studies, large-scale clinical trials, population-based studies, as well as translational research work with the potential to change the course of medical research and improve clinical practice.