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 30 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
Cognitive Behavioural Therapy/ Mindfulness Based Meditation therapy (CBT/MM) remotely for 16 hours between weeks 1 to 16 inclusive + in-person sessions on weeks 2, 7 and 12
Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.
St. Michael's Hospital
Toronto, Ontario, Canada
Recruitment rate
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
Time frame: 2 years
Adherence rate
Feasibility
Time frame: 2 years
Frequency of adverse events
Safety and tolerability
Time frame: 2 years
Patient-Reported Outcomes Measurement Information System Pain Interference (PROMIS) Pain Intensity, 1 a.
PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
Time frame: 20 weeks
Patient-Reported Outcomes Measurement Information System Pain Interference, PROMIS 6 a. Pain Interference,
PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)
Time frame: 20 weeks
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