JMIR Publications

ABSTRACT

Background:

Background:

Chronic pain affects ~8 million Canadians (~20%), impacting their physical and mental health while burdening the healthcare system with costs of upwards of 60 billion dollars a year. Indeed, patients are often trialed on numerous medications over several years without reductions to their symptoms. Therefore, there is an urgent need to identify new therapies for chronic pain to improve patients’ quality of life and availability of treatment options, and to reduce the burden on the healthcare system.

Objective:

Objective:

The primary objective of this study is to examine the feasibility of a parallel 3-arm randomized trial whereby patients are randomized to either intravenous (iv) ketamine alone, Cognitive Behavioural Therapy (CBT) and Mindfulness Meditation Training (MM) (CBT/MM), or the combination of iv ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination iv ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or iv ketamine alone (assessed at week 20 of the study).

Methods:

Methods:

This is a single center, 16-week, three-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael’s Hospital, which receives 1000 referrals per year. Patients will be enrolled in the study for a total of 20 weeks. Participants who are allocated CBT/MM therapy will receive remote weekly psychotherapy from week 1 to week 16 inclusive with health coaching administered through the NexJ Health platform. Patients who are allocated ketamine-infusion therapy will receive monthly ketamine infusion treatments on weeks 2, 7, and 12. Patients who are allocated ketamine + CBT/MM will receive weekly psychotherapy from weeks 1 to 16 inclusive, as well as ketamine infusion treatments on weeks 2,7, and 12. We will be assessing recruitment rates, consent rate, withdrawal rate, adherence, missing data and adverse events as pilot outcome measures. Secondary clinical outcomes include change relative to baseline in pain intensity and pain interference.

Results:

Results:

As of November 1st, 2023, the recruitment process has not been initiated. Given the recruitment, consent, and intervention target of 30 participants for this feasibility study, with each patient undergoing monitoring and treatments for a course of 20 weeks, we expect to complete the study by December 2025

Conclusions:

Conclusion: This study assesses the feasibility of conducting a three-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a chronic neuropathic pain population. The results of this pilot RCT will inform the development of a larger-scale RCT. Future studies will be aimed at including a sufficiently powered sample that will inform about optimal treatment calibration and treatment effect duration Clinical Trial: Trial Registration: ClinicalTrials.gov ID: NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322.