Could ketamine help veterans with back pain and depression?
NCT ID NCT06419439
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study is testing whether ketamine infusions, combined with a brief counseling session, can help veterans who have both chronic low back pain and depression. About 44 veterans will receive four ketamine infusions over two weeks, and some will also get a short behavioral intervention. The goal is to see if this approach is feasible, safe, and acceptable, and to measure changes in pain interference and mood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketamine hydrochloride
- What this could lead to
- If it works, this could point toward a new treatment option that eases both pain and depression in veterans.
- What could go wrong
- This is a small, early pilot study with only 44 participants, so results may not apply widely. Ketamine can cause side effects like dizziness or dissociation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITINGAnn Arbor, Michigan, 48105-2303, United States
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