Clinical trial for Chronic Pain
Official title Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD
ClinicalTrials.gov ID: NCT07009158
What this study is testing
What is Ketamine Infusion?
Ketamine Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- i) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview (66)) ii) Chronic pain (\> 4/10 average pain...
- iii) 18-65 years of age. iv) Capacity to consent
You likely can't join if
- 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...
- iv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report. Participants must be willing to use...
- v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial. Patients with...
- vi) Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion.
See the full eligibility 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
- 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...
- 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...
- 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...
- 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 how well it works 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kingston, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingston, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.