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

Prior treatment

• 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.

Other illness

• Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
• Current uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg).
• History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).
• Known hypersensitivity to any excipient in the ketamine injection formulation.

Lab values

• 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.

Other

• 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).
• Currently participating in another clinical trial for pain or depression.
• Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.
• Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.

• 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.