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

Inclusion Criteria5

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 Criteria13

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.

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.