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

Recruiting now · Phase 2

Conditions studied: Chronic Low Back Pain, Depression

In brief

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.

Key facts

Study ID

NCT06419439

Run by

VA Office of Research and Development

People needed

44

Starts

2025-12-03

Expected to finish

2029-06-30

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Inability to speak English due to the narrative intervention being conducted in English.
• Inability or unwillingness to provide written informed consent (e.g. current delirium).
• Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
• Currently participating in another clinical trial for pain or depression.
• Current uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
• Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.
• History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).
• Any of the following lab values >2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) <2x lower limit of normal or >2x upper limit of normal.
• Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.
• Known hypersensitivity to any excipient in the ketamine injection formulation.
• Previously experienced serious adverse effects with ketamine.
• On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine
• Current or previous abuse of ketamine.

Where it is running

• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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