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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years of age

• 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

• 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

• Capacity to provide informed consent

Locations
Other Locations
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Akash Goel, MD
Akash.Goel@unityhealth.to
416-864-5825
Backup
Janneth Pazmino-Canizares, MSc
Janneth.Pazmino-Canizares@unityhealth.to
416-864-6060
Time Frame
Start Date: 2023-10-12
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 30
Treatments
Active_comparator: Ketamine only
Active_comparator: Psychotherapy only
Experimental: Ketamine + Psychotherapy
Related Therapeutic Areas
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov