Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial

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 HL; (2) psychotherapy (using Cognitive Behavioral Therapy); or (3) a combination of Ketamine HL and psychotherapy.

Inclusion Criteria:≥18 years of ageDiagnosis of chronic neuropathic pain as determined by a pain specialist with moderate-to-severe neuropathic pain as per ID pain questionnaire, with mean pain scores > 3 on a numeric rating scale (NRS), in the 7 days preceding inclusionFor participants of childbearing potential, use highly effective or double-barrier methods of contraception. Abstinence is acceptable if it is the preferred and usual lifestyle of the participantCapacity to provide informed consentExclusion Criteria:Patients less than 18 years of ageCurrent or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorderKnown history of hypersensitivity or allergy to Ketamine-HCLCurrent history of dissociative disordersCurrent concomitant use of theophylline or aminophyllineCurrent elevated intracranial pressurePregnancy or ongoing breastfeeding in female participantsConcomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)Contraindication to receiving Ketamine-HCL (e.g. current or lifetime history of cerebrovascular accident; current significant hypertension [systolic blood pressure higher than 160 mmHg and/or diastolic blood pressure higher than 100 mmHg]; current severe cardiac decompensation [e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions])