Chronic PainPhase 1/2NCT07009158
Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD
A Phase 1/2 study testing Ketamine Infusion and Mindfulness-based cognitive therapy in people with Chronic Pain and Posttraumatic Stress Disorder (PTSD), run by Dr. Yuliya Knyahnytska at 1 site in Canada.
Trial summary
The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain, Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Ketamine Infusion and Mindfulness-based cognitive therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 31 Mar 2026to Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)).
- 18-65 years of age. iv) Capacity to consent
Who cannot join
- Currently receiving or received ketamine or psychotherapy to treat PTSD in previous 8 weeks.
- Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse.
- 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).
- 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.
- 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.
- Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion.
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- 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).
- 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).
- 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.
- Inability to secure a responsible adult to accompany them back home after ketamine sessions.
- Inability to take part in virtual care, no valid email address. xiii) Inability to safely secure IV access.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Providence Care Hospital / Kingston Health Sciences Centre Hotel Dieu Hospital site
Kingston, Ontario, K7L 4X3
Etienne Bisson, PhD, 855-544-3400 ext. 23347, chronicpain.research@kingstonhsc.ca
About this study
Official title: Ketamine Assisted Psychotherapy to Improve Quality of Life in Veterans and Civilians With Comorbid Chronic Pain and Posttraumatic Stress Disorder: an Open-label Randomized Controlled Trial.
The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions. The objectives of the pilot study are to 1) assess the feasibility of the trial methods and 2) assess the feasibility and tolerability of ketamine treatment in combination with psychotherapy. The main questions the future full trial would aim to answer are:
- Does the combination of ketamine infusion treatment and mindfulness therapy improve the quality of life in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
- Does the combination of ketamine infusion treatment and mindfulness therapy improve disability, and depressive, PTSD and pain symptoms in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
- Does implementing a brief ketamine infusion protocol safe and tolerable to treat chronic pain and PTSD?
Read more
Researchers will compare ketamine infusion treatment combined with mindfulness therapy to mindfulness therapy alone to see if the combined treatment works better to treat chronic pain and PTSD.
Participants will:
- Attend 6 visits with a research team member to complete assessments and questionnaires.
- Attend 4 ketamine treatment over 2 weeks, if allocated to the experimental group.
- Attend 8 mindfulness therapy group sessions online (1 per week).
- Log mindfulness exercises completed during the study period.
- Conditions
- Chronic Pain, Posttraumatic Stress Disorder (PTSD)
- Being tested
- Ketamine Infusion, Mindfulness-based cognitive therapy
- Keywords
- Ketamine, Mindfulness-based Cognitive Therapy
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine InfusionDrug
Ketamine hydrochloride (DIN: 02246795, 02246796) will be administered over 40-min intravenous (IV) infusion twice per week on non-consecutive days for the first two weeks of study treatment (four treatment sessions in total). We will use a standard dose of 0.5mg/kg which has demonstrated efficacy in safety in individuals with PTSD.
Mindfulness-based cognitive therapyBehavioural
The Mindfulness-based cognitive therapy (MBCT) will be an 8-week group program adapted from a protocol developed to treat PTSD to include psychoeducation about chronic pain and mutual maintenance factors through which chronic pain and PTSD facilitate each other. The MBCT group will be delivered by trained professionals in weekly 2-hour sessions through Microsoft Teams. The 8-week program will include 1) mindfulness techniques; 2) psychoeducation regarding chronic pain, PTSD and stress responses; 3) psychoeducation on mutual maintenance factors that contribute to negative interactions between pain and PTSD symptoms, 4) promoting mindful awareness of these factors' impact on daily life and 5) feedback and supportive group discussion of exercises. Participants will be asked to complete daily mindfulness exercises between sessions to practice skills learned for a recommended minimum of 20 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| KAP group | Experimental | The Ketamine-assisted psychotherapy (KAP) group will receive 4 ketamine infusion treatments and 8 sessions of mindfulness therapy. Receives: Drug: Ketamine Infusion; Behavioral: Mindfulness-based cognitive therapy |
| MT group | Active comparator | The mindfulness therapy (MT) group will receive only the psychotherapy treatment (8 sessions mindfulness therapy). Receives: Behavioral: Mindfulness-based cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
Measured using the Short-Form-12 Health Survey (SF-12v2)
Measured: Enrollment, 1 week pre-treatment, mid-treatment (1month), post-treatment (2months) and follow-up (3months)
Secondary outcomes (7)
Depressive symptoms
Measured using the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Suicide risk
Suicide risk will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
PTSD symptoms
Measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Pain Severity
Pain Severity will be measured using the Brief Pain Inventory - Short Form (BPI)
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Pain Interference
Pain Interference will be measured using the Brief Pain Inventory - Short Form (BPI)
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Disability
Measured using the WHO Disability Assessment Schedule (WHODAS 2.0- 12 items)
Measured: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Adverse events
Measured using a adverse events form.
Measured: From enrollment to 1 month after the end of the 8-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start31 Mar 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Yuliya Knyahnytska
- Sponsor type
- University, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Providence Care Hospital
- Responsible party
- Sponsor-investigator, Dr. Yuliya Knyahnytska, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009158
- Sponsor's protocol ID
- TRAQ-6043701
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Assisted Psychotherapy to Improve Quality of Life in Veterans and Civilians With Comorbid Chronic Pain and Posttraumatic Stress Disorder: an Open-label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07009158
- Acronym / sponsor ID
- TRAQ-6043701
- Conditions
- Chronic Pain, Posttraumatic Stress Disorder (PTSD)
- Keywords
- Ketamine, Mindfulness-based Cognitive Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Dr. Yuliya KnyahnytskaUniversity, hospital or other
- Collaborators
- Kingston Health Sciences Centre, Providence Care Hospital
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions. The objectives of the pilot study are to 1) assess the feasibility of the trial methods and 2) assess the feasibility and tolerability of ketamine treatment in combination with psychotherapy. The main questions the future full trial would aim to answer are:
- Does the combination of ketamine infusion treatment and mindfulness therapy improve the quality of life in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
- Does the combination of ketamine infusion treatment and mindfulness therapy improve disability, and depressive, PTSD and pain symptoms in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
- Does implementing a brief ketamine infusion protocol safe and tolerable to treat chronic pain and PTSD?
Researchers will compare ketamine infusion treatment combined with mindfulness therapy to mindfulness therapy alone to see if the combined treatment works better to treat chronic pain and PTSD.
Participants will:
- Attend 6 visits with a research team member to complete assessments and questionnaires.
- Attend 4 ketamine treatment over 2 weeks, if allocated to the experimental group.
- Attend 8 mindfulness therapy group sessions online (1 per week).
- Log mindfulness exercises completed during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAP group | Experimental | Drug: Ketamine Infusion, Behavioral: Mindfulness-based cognitive therapyThe Ketamine-assisted psychotherapy (KAP) group will receive 4 ketamine infusion treatments and 8 sessions of mindfulness therapy. |
| MT group | Active comparator | Behavioral: Mindfulness-based cognitive therapyThe mindfulness therapy (MT) group will receive only the psychotherapy treatment (8 sessions mindfulness therapy). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)).
- 18-65 years of age. iv) Capacity to consent
Key exclusion criteria (11 listed)
- Currently receiving or received ketamine or psychotherapy to treat PTSD in previous 8 weeks.
- Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse.
- 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).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine InfusionKetamine hydrochloride (DIN: 02246795, 02246796) will be administered over 40-min intravenous (IV) infusion twice per week on non-consecutive days for the first two weeks of study treatment (four treatment sessions in total). We will use a standard dose of 0.5mg/kg which has demonstrated efficacy in safety in individuals with PTSD. | Drug | KAP group |
| Mindfulness-based cognitive therapyThe Mindfulness-based cognitive therapy (MBCT) will be an 8-week group program adapted from a protocol developed to treat PTSD to include psychoeducation about chronic pain and mutual maintenance factors through which chronic pain and PTSD facilitate each other. The MBCT group will be delivered by trained professionals in weekly 2-hour sessions through Microsoft Teams. The 8-week program will include 1) mindfulness techniques; 2) psychoeducation regarding chronic pain, PTSD and stress responses; 3) psychoeducation on mutual maintenance factors that contribute to negative interactions between pain and PTSD symptoms, 4) promoting mindful awareness of these factors' impact on daily life and 5) feedback and supportive group discussion of exercises. Participants will be asked to complete daily mindfulness exercises between sessions to practice skills learned for a recommended minimum of 20 minutes per day. | Behavioural | KAP group, MT group |
Primary outcome
Health-Related Quality of Life
Time frame: Enrollment, 1 week pre-treatment, mid-treatment (1month), post-treatment (2months) and follow-up (3months)
Measured using the Short-Form-12 Health Survey (SF-12v2)
7 secondary outcomes
Depressive symptoms
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Suicide risk
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
PTSD symptoms
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Pain Severity
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Pain Interference
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Disability
Time frame: At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)
Adverse events
Time frame: From enrollment to 1 month after the end of the 8-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine Infusion and Mindfulness-based cognitive therapy in people with Chronic Pain and Posttraumatic Stress Disorder (PTSD), run by Dr. Yuliya Knyahnytska at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Etienne J Bisson, PhD (16135443400 ext. 23347, etienne.bisson@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: Enrollment, 1 week pre-treatment, mid-treatment (1month), post-treatment (2months) and follow-up (3months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.