Chronic Pain study: Ketamine Infusion
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?
An investigational intravenous infusion being studied for chronic pain and PTSD.
Also referred to as Ketamine.
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 study wants to see if adding ketamine to mindfulness therapy improves quality of life, disability, depression, PTSD, and pain for people with both conditions.
- Who it's for
- Adults who have both chronic pain and post‑traumatic stress disorder.
- What's involved
- Participants will have six research visits, four ketamine infusions over two weeks if in the ketamine group, and eight online mindfulness therapy sessions. They will also track mindfulness exercises they do at home.
- Time commitment
- The study lasts about two weeks of treatment plus follow‑up visits, with a total of six research visits and eight therapy sessions.
- 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.
- v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial.
- 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.
- iv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report.
- v) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Kingston, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.