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Ketamine-assisted Treatment for Veterans with Chronic Low Back Pain and Depression

This study is testing a new approach for Veterans who experience both ongoing low back pain (chronic low back pain) and depression. It combines ketamine hydrochloride infusions with a brief behavioral intervention. Researchers want to see if this combination can help reduce pain and improve mood. You might be eligible if you are a Veteran aged 18 or older with moderate to severe chronic low back pain (at least 4 out of 10 on a pain scale for 3 months or more) and significant symptoms of depression. The main goal is to see if this treatment helps with how much pain interferes with your daily life. The study is currently unclear on its recruitment status, but plans to enroll about 44 participants.

Study design
This is a pilot study, meaning it's an early test of the treatment. It has two parts: an initial open-label (everyone knows what treatment they're getting) single-arm pilot with 5 participants, followed by a single-blind (you won't know which treatment arm you're in) randomized controlled trial with 44 participants.
What's involved
Participants in Arms 1, 2, and 3 will receive four ketamine hydrochloride intravenous infusions, given twice a week. Some participants will also receive educational materials or a brief narrative intervention.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for pain interference will be measured about 8-10 days after you are assigned to a study group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06419439

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

Recruiting
PHASE2Ages 18+Interventional
VA Office of Research and Development
~44 participants
Updated 2025-12-18 on ClinicalTrials.gov
What's tested:Ketamine hydrochlorideMinimally Enhanced Usual CareBrief narrative intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)
Measured over Visit 7 (8-10 days post randomization)

Conditions

Chronic Low Back Pain
Depression

Explore related trials

Chronic low back painDepression

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Victoria D Powell, MD · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI

Who to contact

Victoria D Powell, MD
[email protected]
(734) 845-3072
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)Visit 7 (8-10 days post randomization)

    Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.