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

Launched by UNITY HEALTH TORONTO · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help people who suffer from chronic neuropathic pain, which is a type of pain caused by nerve damage. The study will involve 60 participants who are experiencing moderate to severe pain, with the goal of understanding how effective treatments like Ketamine (a medication) and psychotherapy (talk therapy) can be in relieving this pain. Participants will be randomly assigned to one of three groups: one group will receive Ketamine, another will receive psychotherapy using Cognitive Behavioral Therapy, and the third group will receive both treatments together.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with chronic neuropathic pain. They should also be able to provide informed consent, meaning they understand what the study involves. However, some individuals may not qualify, such as those with certain mental health conditions, those who are pregnant or breastfeeding, or those with specific health issues. Participants in the trial can expect to receive either one or both treatments and will help researchers learn more about how to manage and improve chronic pain effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years of age
• • 2. Diagnosis 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 inclusion
• • 3. For 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 participant
• • 4. Capacity to provide informed consent
• Exclusion Criteria:
• • 1. Patients less than 18 years of age
• • 2. Current or lifetime history of schizophrenia, psychotic disorder, bipolar disorder, or borderline personality disorder
• • 3. Known history of hypersensitivity or allergy to Ketamine-HCL
• • 4. Current history of dissociative disorders
• • 5. Current concomitant use of theophylline or aminophylline
• • 6. Current elevated intracranial pressure
• • 7. Pregnancy or ongoing breastfeeding in female participants
• • 8. Concomitant active substance use in the 6 months preceding enrolment (amphetamines, alcohol, and ketamine)
• • 9. 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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])