Psychotherapy combined with Ketamine for chronic neuropathic pain relief
Psychotherapy for Ketamine's Enhanced Durability in Chronic Neuropathic Pain: A Randomized Controlled Pilot Trial
This study is testing if combining ketamine with therapy can help people with chronic nerve pain feel better and manage their pain more effectively.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05639322 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to explore the effectiveness of combining Ketamine Hydrochloride with Cognitive Behavioral Therapy (CBT) to improve pain management in patients suffering from chronic neuropathic pain. The study will enroll 60 participants who will be randomized into three groups: one receiving Ketamine alone, another receiving CBT, and a third receiving both treatments. The primary goal is to assess the feasibility of this combined approach in enhancing pain relief and durability of treatment effects.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with moderate-to-severe chronic neuropathic pain.
Not a fit: Patients with a history of certain psychiatric disorders or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option that significantly improves pain management for patients with chronic neuropathic pain.
How similar studies have performed: While the combination of Ketamine and psychotherapy is a novel approach, similar studies exploring the use of Ketamine for pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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 \[e.g. presence of dyspnea, peripheral edema, elevated jugular venous pressure, hepatomegaly, pulmonary rales, pleural effusions\])
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Akash Goel, MD
- Email: Akash.Goel@unityhealth.to
- Phone: 416-864-5825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.