Psychotherapy for Ketamine’s Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Chronic pain affects approximately 8 million Canadians (~20%), impacting their physical and mental health while burdening the health care system with costs of upwards of US $60 billion 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, increase the availability of treatment options, and reduce the burden on the health care system. OBJECTIVE: The primary objective of this study is to examine the feasibility of a parallel 3-arm pilot randomized controlled trial whereby patients are randomized to either intravenous ketamine alone, cognitive behavioral therapy (CBT) and mindfulness meditation (MM) training (CBT/MM), or the combination of intravenous ketamine and CBT/MM. The secondary outcome is to assess the durability and efficacy of combination intravenous ketamine and CBT/MM for treatment of chronic pain as compared to CBT/MM or intravenous ketamine alone (assessed at week 20 of the study). METHODS: This is a single-center, 16-week, 3-arm pilot study that will take place at the Chronic Pain Clinic at St. Michael's Hospital, Toronto, Ontario, 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 of health coaching administered through the NexJ Health Inc (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 rates, withdrawal rates, adherence, missing data, and adverse events as pilot outcome measures. Secondary clinical outcomes include changes relative to baseline in pain intensity and pain interference. RESULTS: As of November 1, 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: This study assesses the feasibility of conducting a 3-arm randomized controlled trial to examine the effects of ketamine administration with the concurrent use of CBT/MM in a population with chronic neuropathic pain. The results of this pilot randomized controlled trial will inform the development of a larger-scale randomized controlled trial. Future studies will be aimed at including a sufficiently powered sample that will inform decisions about optimal treatment calibration and treatment effect duration. TRIAL REGISTRATION: ClinicalTrials.gov NCT05639322; https://classic.clinicaltrials.gov/ct2/show/NCT05639322. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54406.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.035 | 0.024 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.011 | 0.007 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.005 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.006 | 0.008 |
| Insufficient payload (model declined to judge) | 0.069 | 0.010 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".