Ketamine-Enhanced Treatment for Veterans with Chronic Low Back Pain and Depression Pilot Study of Ketamine Infusions Followed by Behavioral Therapy

What this Trial Is About

This research aims to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans who have chronic low back pain along with depression. These conditions are common causes of disability in the U.S., and Veterans with both conditions often face more challenges such as increased functional limitations and higher healthcare costs. The study is a Phase 2 pilot designed to test new combined approaches addressing both pain and mood symptoms simultaneously. The study has two phases. The first phase is an open-label pilot with five Veterans receiving four ketamine hydrochloride infusions administered intravenously twice weekly, followed by a brief narrative behavioral intervention. The second phase is a single-blind randomized controlled trial with 44 participants divided into two groups one group receives ketamine infusions plus the brief behavioral intervention and minimally enhanced usual care educational materials, while the control group receives only the educational materials. The ketamine dose is 0.5 mgkg per infusion. Participants will be monitored through various assessments, including pain interference measured by the PROMIS Pain Interference Short Form, pain intensity by a numeric rating scale, and depression symptoms by the Quick Inventory of Depressive Symptoms. These evaluations occur about 8 to 10 days after randomization. Researchers will also collect participant feedback and assess the studys feasibility. The total study duration for participants is approximately four months, during which safety and adherence will be closely observed.

Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression