This Phase IV, randomised controlled trial (n=30) will evaluate the effectiveness of ketamine and psychotherapy in managing chronic neuropathic pain. Participants aged 18 and older with moderate-to-severe neuropathic pain will be assigned to one of three groups: ketamine hydrochloride (1 mg/kg IV, up to 100 mg) administered on weeks 2, 7, and 12, cognitive behavioural therapy (CBT) combined with mindfulness-based meditation delivered remotely for 16 hours over weeks 1 to 16 with in-person sessions on specified weeks, or a combination of both interventions. The trial aims to assess the feasibility of these treatments, focusing on recruitment and adherence rates, as well as the frequency of adverse events over a two-year period. Participants will be monitored for their response to the interventions, with the primary outcomes including the rate of recruitment, adherence to the treatment protocol, and any adverse events experienced during the study. The trial is sponsored by Unity Health Toronto and is set to conclude in July 2025.
The purpose of the study is to investigate new therapies to alleviate pain on neuropathic chronic pain. At this time, the main purpose is to complete a feasibility or pilot study with 60 participants suffering from neuropathic chronic pain. Participants will be randomized to (1) Ketamine (Hydrochloride) HCL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.
Unmatched intervention: Cognitive Behavioral Therapy