St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
NCT Number: NCT05639322
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Toronto, Ontario, M5B 1W8, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
Recruitment rate and withdrawal rate (Acceptability and feasibility study)
Time frame: 2 years
Feasibility
Time frame: 2 years
Safety and tolerability
Time frame: 20 weeks
PROMIS-PI - 1 a. pain intensity scale- 0 to 10 (The higher the number the higher the pain intensity)
Time frame: 20 weeks
PROMIS-PI -Short form 6 a. - pain interference scale- 6 items, 5 likert scale The higher the score the higher the interference from pain)
Unity Health Toronto
Other
Acronym: PSYKED-NP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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