RecruitingPhase 2NCT06419439

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

Sponsor

VA Office of Research and Development

Enrollment

44 participants

Start Date

Dec 3, 2025

Study Type

INTERVENTIONAL

Conditions

Depression Chronic Low-back Pain

Summary

This is a pilot study to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans with chronic low back pain and depression.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ketamine-assisted therapy for veterans who have both chronic low back pain and depression. Ketamine is a medicine that may help reset pain signals and mood. Participants will also receive integrative therapy (counseling and support) alongside the treatment. **You may be eligible if...** - You are a veteran with moderate to severe chronic low back pain lasting at least 3 months - You also have significant depression symptoms - Your pain and depression medications have not changed in the past 4 weeks - You are medically stable (no hospitalizations longer than 3 days in the past month) - You have a trusted adult who can drive you home after sessions **You may NOT be eligible if...** - You have planned surgeries, injections, or other new back or depression treatments in the next 4 months - You have active or recent substance misuse or psychosis - You have serious heart or other medical conditions that make ketamine unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKetamine hydrochloride

Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.

BEHAVIORALMinimally Enhanced Usual Care

Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT).

BEHAVIORALBrief narrative intervention

Participants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions. Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention.