RecruitingChronic Low Back PainDepression
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
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.
Sponsor: VA Office of Research and Development
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Michigan
Ann Arbor
Source: ClinicalTrials.gov · NCT06419439 · last updated 2025-12-18