This open-label, randomised controlled trial (n=30) will study whether ketamine (four infusions over two weeks) combined with mindfulness-based cognitive therapy improves quality of life, pain, depression, and PTSD symptoms more effectively than mindfulness therapy alone in adults with both chronic pain and PTSD.
The Phase I/II pilot trial, sponsored by Queen’s University in Canada, aims to assess the feasibility, safety, and tolerability of combining intravenous ketamine treatment with psychotherapy.
Participants aged 18–64 with diagnosed post-traumatic stress disorder (PTSD) and chronic pain (lasting more than three months with average pain intensity over 4/10) will be randomly assigned to receive either the combined treatment or mindfulness therapy alone. Those in the ketamine group will undergo four ketamine infusions over two weeks alongside eight weekly online group mindfulness sessions. The study excludes individuals with severe psychiatric disorders, recent ketamine or psychotherapy treatments, high suicidal risk, or medical conditions that could interfere with treatment. Researchers aim to use this pilot to inform a larger trial and determine whether the dual approach leads to better outcomes in this complex patient population.
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