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Recruiting Phase 2 NCT06419439

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

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Plain-language summary for patients

Trial Parameters

Condition Chronic Low Back Pain
Sponsor VA Office of Research and Development
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 44
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-03
Completion 2028-12-01
Interventions
Ketamine hydrochlorideMinimally Enhanced Usual CareBrief narrative intervention

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Brief 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 Criteria

Inclusion Criteria: * Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score 60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score 11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR). * Medically stable (no hospitalizations in the past month lasting 3 days). * No changes in pain or depression medication regimen in 4 weeks. * No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration). * Participants must have an adult who can drive them home after the ketamine treatments. Exclusion Criteria: * Inability to speak English due to the narrative intervention being conducted in English. * Inability or unwillingness to provide written inform

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