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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring the use of ketamine, a medication often used for anesthesia, to help Veterans who suffer from chronic low back pain and depression. The study aims to see if ketamine infusions, combined with a brief therapy session, are safe and acceptable for this group of individuals. It is designed for Veterans aged 65 to 74 who experience moderate to severe back pain that affects their daily life and have significant symptoms of depression. Participants will need to be medically stable and not have made recent changes to their pain or depression medications. They also need to have a responsible adult who can drive them home after the treatment.

If eligible, participants will receive ketamine infusions and then engage in a short behavioral intervention. Throughout the study, researchers will closely monitor their experiences to ensure safety and gather feedback on how well they are coping with their pain and depression. It's important to note that those with certain health conditions or who are currently involved in other clinical trials will not be able to participate. This study is not yet recruiting participants, but it will provide valuable insights into new treatment options for Veterans struggling with these challenging conditions.

Gender

ALL

Eligibility criteria

• 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.