Ketamine Infusions with Mindfulness Therapy for Chronic Pain and PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional pilot study evaluating the feasibility of a randomized approach that combines ketamine infusions with mindfulness-based cognitive therapy (MBCT) for adults with concurrent chronic pain and PTSD. The study aims to determine whether the combination is tolerable and practical to run, and whether it may improve quality of life, disability, and symptoms of depression, PTSD, and pain compared with MBCT alone. Participants must have chronic pain lasting at least 3 months and a DSM-5 PTSD diagnosis, be 18–65 years old, and meet safety criteria. Exclusion criteria include recent ketamine or PTSD psychotherapy, substance use disorders, unstable medical issues, or pregnancy. The investigation is conducted at Providence Care Hospital and Kingston Health Sciences Centre in Kingston, Ontario, with lead sponsor Dr. Yuliya Knyahnytska and collaborating centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Providence Care Hospital / Kingston Health Sciences Centre Hotel Dieu Hospital site
  Kingston, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Etienne J Bisson, PhD
• Email: etienne.bisson@kingstonhsc.ca
• Phone: 16135443400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.