Three Infusions in Twelve Weeks: A Toronto Pain Trial Ran a Very Different Protocol
A Toronto team paired ketamine infusions with structured psychotherapy for chronic nerve pain. The results were published in Med on August 13, 2026. Most coverage led with the outcome. The more useful part is the protocol. The trial used three infusions spread across twelve weeks, not six infusions inside three.
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| Key Takeaway | Detail |
|---|---|
| The trial | PSYKED-NP, run at St. Michael’s Hospital in Toronto from October 2023 to July 2025 |
| Size and design | 30 adults with chronic neuropathic pain, randomized to three arms, single-blind outcome assessment |
| Ketamine protocol | 1 mg/kg IV, capped at 100 mg, infused over two hours, at weeks 2, 7 and 12 |
| Therapy protocol | 16 hours of remote CBT and mindfulness across 16 weeks, with in-person sessions on infusion days |
| Reported result | Roughly 80 percent of the combined arm hit a meaningful drop in pain interference, versus 50 to 60 percent in single-treatment arms |
| The catch | Pain scores were secondary outcomes. The registered primary outcomes were feasibility measures |
What the Toronto Team Ran
The study is registered as NCT05639322 under the acronym PSYKED-NP. The sponsor is Unity Health Toronto. Collaborators included the University of Toronto and York University.
Thirty adults with specialist-confirmed chronic neuropathic pain enrolled. All had moderate to severe pain, meaning a mean rating above 3 out of 10. Enrollment ran from October 2023 to July 2025.
Participants were randomized to one of three arms. One received ketamine only. One received psychotherapy only. One received both.
The Protocol Is the Headline
Here is the regimen. Ketamine at 1 mg/kg intravenously, capped at 100 mg. Each infusion ran two hours. Patients received three infusions total, at weeks 2, 7 and 12.
Compare that to common US practice. Many clinics run roughly 0.5 mg/kg over 40 minutes. Many deliver six infusions inside two or three weeks.
Toronto did close to the opposite. Higher dose per session, longer infusion, far fewer sessions, stretched across three months. That is a different chair-time model and a different billing model.
Why Space the Infusions Out
The trial name explains the reasoning. PSYKED-NP stands for Psychotherapy for Ketamine’s Enhanced Durability in Chronic Neuropathic Pain.
Durability is the target. Relief that fades between infusions is the central problem in ketamine pain practice. Patients improve, then slide back, then return for more.
The hypothesis is that therapy delivered in the gaps holds the gains. Lead author Dr. Akash Goel described the drug as clearing ground for other work. “Ketamine allows us to basically remove those weeds and plant new seeds for new flowers to grow,” he said.
What the Psychotherapy Arm Involved
The therapy component was specific, which matters. It combined cognitive behavioral therapy with mindfulness-based meditation.
Delivery was mostly remote. Participants received 16 hours across weeks 1 through 16. In-person sessions were timed to align with the infusion weeks.
That structure is worth noting. Sixteen hours of remote therapy is not an expensive add-on. It is closer to a care coordination line item than a second clinical service. What the therapy component actually is has been contested elsewhere, as in the argument over psilocybin session support.
What They Measured and What They Found
The secondary outcomes were PROMIS Pain Intensity and PROMIS Pain Interference at 20 weeks. Interference is the more meaningful of the two. It asks whether pain is stopping you from doing things.
All three groups improved on pain intensity, depression and anxiety. The combined group did better on interference. Roughly 80 percent reached a clinically meaningful reduction, against 50 to 60 percent in the single-treatment arms.
No serious adverse events occurred in any arm.
The Limits Are Real, and the Authors Say So
This was a pilot. The registered primary outcomes were recruitment, withdrawal, adherence and adverse event frequency. In other words, the study was designed to test whether the trial could be run.
Pain scores were secondary. With 30 people across three arms, each group held about ten patients. An 80 percent response rate in that group is eight people.
Goel said it plainly. The findings do not conclusively show that the combination beats either treatment alone. He called the signals promising, which is the right word for a sample this size. Blinding is also imperfect, since patients receiving 1 mg/kg over two hours generally know it.
Who Was Excluded
The exclusion list maps closely to standard ketamine screening. Schizophrenia, psychotic disorders, bipolar disorder and borderline personality disorder disqualified candidates. So did dissociative disorders.
Medical exclusions covered elevated intracranial pressure, cerebrovascular history, uncontrolled hypertension and severe cardiac dysfunction. Pregnancy and recent substance use were also disqualifying.
Nothing there should surprise an experienced practice. It is a reasonable benchmark against your own intake criteria.
No Industry Money Behind It
Funding came from the Canadian Pain Society, the St. Michael’s Hospital Innovation Fund and Physician Services Incorporated. There is no pharmaceutical sponsor and no device maker.
That is worth stating because it is unusual. A good deal of recent psychedelic and ketamine research carries a commercial interest that shapes how results get promoted. This one does not.
What a Clinic Would Have to Change
Running something similar means three shifts. Longer infusion slots, since two hours is roughly triple a standard 40 minute chair booking. Fewer visits per patient, which changes per-patient revenue. And a therapy partner or in-house clinician who can deliver structured CBT remotely.
The third is the real barrier. Most infusion practices are not staffed for 16 hours of protocolized therapy per patient. Some already run adjacent services, as we noted when looking at how clinic infrastructure maps to trial protocols.
The Bottom Line
Do not read this as proof that adding therapy improves nerve pain outcomes. Thirty patients cannot carry that claim.
Read it as a well documented protocol that a larger trial can now test. It also fits a pattern in current pain research, including work suggesting ketamine may relieve pain without relying on dissociation.
Patients looking for supervised care can start with our directory of verified ketamine clinics.
This article is for informational purposes and is not medical advice. Ketamine for chronic pain is an off-label use. Discuss treatment options with a qualified clinician.
