NCT05639322

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Ketamine-HCL IV 1mg/kg (up to 100 mg) over 2 hours, on weeks 2, 7, and 12.
BEHAVIORAL	Cognitive Behavioral Therapy	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
OTHER	Ketamine + Cognitive Behavioral Therapy	Ketamine-HCL + CBT/MM according to the same directions specified in Arm 1 and Arm 2.

Timeline

• Start date: 2023-10-12
• Primary completion: 2025-07-24
• Completion: 2025-07-24
• First posted: 2022-12-06
• Last updated: 2026-04-07

Locations

1 site across 1 country: Canada