NCT06419439 Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
| NCT ID | NCT06419439 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Chronic Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-12-03 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2025-12-03 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Victoria D Powell, MD
PRINCIPAL INVESTIGATOR
VA Ann Arbor Healthcare System, Ann Arbor, MI
Frequently Asked Questions
Who can join the NCT06419439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06419439 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06419439 currently recruiting?
Yes, NCT06419439 is actively recruiting participants. Contact the research team at Victoria.Powell2@va.gov for enrollment information.
Where is the NCT06419439 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06419439 clinical trial?
NCT06419439 is sponsored by VA Office of Research and Development. The principal investigator is Victoria D Powell, MD at VA Ann Arbor Healthcare System, Ann Arbor, MI. The trial plans to enroll 44 participants.