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Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: Protocol for a Pilot Randomized
Akash Goel1,2, Bhavya Kapoor1,3, Hillary Chan4
1Department of Anesthesia and Pain Medicine, St Michael's Hospital, Toronto, ON, Canada.
JMIR Research Protocols
|April 17, 2024
Summary
This pilot study evaluates the feasibility of combining ketamine infusion with cognitive behavioral therapy and mindfulness meditation (CBT/MM) for chronic pain. Results will inform larger trials on novel pain management strategies.
Area of Science:
- Pain Management
- Clinical Trial Feasibility
- Neuropathic Pain Therapeutics
Background:
- Chronic pain affects 20% of Canadians, leading to significant health and economic burdens.
- Current treatments are often ineffective, necessitating novel therapeutic approaches.
- There is an urgent need for new therapies to improve quality of life and reduce healthcare costs.
Purpose of the Study:
- To assess the feasibility of a 3-arm pilot randomized controlled trial (RCT) for chronic pain.
- To compare intravenous ketamine, CBT/MM, and their combination.
- To evaluate the durability and efficacy of combination therapy at 20 weeks.
Main Methods:
- A single-center, 16-week, 3-arm pilot RCT involving 30 participants.
- Interventions include ketamine infusion, CBT/MM, or both.
- Pilot outcomes include recruitment, consent, adherence, and adverse events; secondary outcomes are pain intensity and interference.
Main Results:
- Recruitment has not yet begun; study completion is anticipated by December 2025.
- The study aims to recruit 30 participants for a 20-week monitoring and treatment course.
- Pilot outcome measures will guide future trial design.
Conclusions:
- This study assesses the feasibility of a 3-arm RCT for chronic neuropathic pain using ketamine and CBT/MM.
- Findings will inform the design of a larger, powered RCT.
- Future research will optimize treatment calibration and assess long-term effects.
