Recruiting

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

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.

ClinicalTrials.gov IDNCT06419439
PhasePHASE2
Enrollment44
SponsorVA Office of Research and Development
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Chronic Low Back Pain, Depression

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.