Can ketamine boost mindfulness therapy for people facing pain and PTSD?
NCT ID NCT07009158
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether ketamine infusions combined with mindfulness-based cognitive therapy improve quality of life more than mindfulness therapy alone in adults who have both chronic pain and posttraumatic stress disorder. The pilot study enrolls 30 veterans and civilians aged 18 to 65. Participants attend assessments, and those assigned to the experimental group receive four ketamine infusions over two weeks while all participants take part in an eight-week online mindfulness group program.
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 given as an intravenous infusion alongside mindfulness-based cognitive therapy
- What this could lead to
- If the approach works, it could offer a combined treatment that eases both chronic pain and PTSD symptoms and improves daily quality of life for people living with both conditions.
- What could go wrong
- This is a small early-stage pilot with 30 participants, so it mainly tests whether the study methods and ketamine treatment are practical and tolerable. Ketamine can cause temporary dissociation, blood pressure changes, and other side effects, and the results may not hold in a larger trial.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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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: i) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview (66)) ii) Chronic pain (\> 4/10 average pain reported for longer than 3 months (per (67)). iii) 18-65 years of age. iv) Capacity to consent Exclusion Criteria: i) Currently receiving or received ketamine or psychotherapy to treat PTSD in previous 8 weeks. ii) Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse. iii) Concomitant unstable major medical or neurological conditions, or laboratory/imaging results as considered by the study treating physician to interfere with trial participation (e.g. poorly controlled blood pressure, BMI \>35). iv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report. Participants must be willing to use a medically acceptable method of birth control which include abstinence, hormonal (birth control pills, patch, hormone injections or implants), diaphragm with spermicide or cervical cap, IUD, condom used together with spermicide, surgical sterilization (hysterectomy or partner's vasectomy) and post-menopausal more than 2 years. v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial. Patients with lifelong diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective disorder will be excluded. Patients with primary Obsessive Compulsive Disorder, Substance Use Disorder (dependence and abuse), Seasonal Affective Disorder, or Generalized Anxiety Disorder at time of assessment will be excluded. Primary severe borderline personality disorder and any other personality disorders that potentially may interfere with treatment administration will also be excluded. vi) Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion. vii) Use of medications that might interfere with ketamine efficacy such as benzodiazepines with a dose equivalent to lorazepam 2mg/day or higher, and anti-convulsant (except for pregabalin and gabapentin). viii) Deemed not appropriate to engage in group psychotherapy. ix) Inability to communicate in spoken and written English fluently enough to complete the required study assessments or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete clinical assessments). x) Cognitive or physical impairment severe enough to interfere with IV ketamine administration and the subject's ability to stay in the same place for a 2-hr monitoring supervision. xi) Inability to secure a responsible adult to accompany them back home after ketamine sessions. xii) Inability to take part in virtual care, no valid email address. xiii) Inability to safely secure IV access.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Providence Care Hospital / Kingston Health Sciences Centre Hotel Dieu Hospital site
RECRUITINGKingston, Ontario, K7L 4X3, Canada
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