Can ketamine boost mindfulness therapy for people facing pain and PTSD?

NCT ID NCT07009158

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Sep 2029

An estimate. End dates often move.

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 to 64 years

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic pain are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Providence Care Hospital / Kingston Health Sciences Centre Hotel Dieu Hospital site

    RECRUITING

    Kingston, Ontario, K7L 4X3, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.