Can psychotherapy extend Ketamine's pain relief? small study hopes to find out
NCT ID NCT05639322
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tested whether adding cognitive behavioral therapy and mindfulness meditation to ketamine infusions could make pain relief last longer for people with chronic nerve pain. Thirty adults with moderate-to-severe neuropathic pain were randomly assigned to receive ketamine alone, therapy alone, or both together. The main goal was to see if the combined approach is feasible and safe, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ketamine hydrochloride (an anesthetic drug) and cognitive behavioral therapy/mindfulness meditation
- What this could lead to
- If successful, this could point toward a longer-lasting treatment for chronic nerve pain without needing frequent repeat infusions.
- What could go wrong
- This is a very small pilot study (30 people) focused on feasibility, not proof of effectiveness. Results may not apply to everyone with neuropathic pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
30 people
The number who actually took part.
- Started
-
Oct 2023
- Finished
-
Jul 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥18 years of age 2. Diagnosis of chronic neuropathic pain as determined by a pain specialist with moderate-to-severe neuropathic pain as per ID pain questionnaire, with mean pain scores \> 3 on a numeric rating scale (NRS), in the 7 days preceding inclusion 3. For participants of childbearing potential, use highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participant 4. Capacity to provide informed consent Exclusion Criteria: 1. Patients less than 18 years of age 2. Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder 3. Known history of hypersensitivity or allergy to Ketamine-HCL 4. Current history of dissociative disorders 5. Current concomitant use of theophylline or aminophylline 6. Current elevated intracranial pressure 7. Pregnancy or ongoing breastfeeding in female participants 8. Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine) 9. Contraindication to receiving Ketamine-HCL (e.g. current or lifetime history of cerebrovascular accident; current significant hypertension \[systolic blood pressure higher than 160 mmHg and/or diastolic blood pressure higher than 100 mmHg\]; current severe cardiac decompensation \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
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