Ketamine-assisted Integrative Treatment for Chronic Low Back Pain & Depression
VA study of ketamine-assisted integrative treatment for veterans with chronic low back pain and co-occurring depression.
This is an interventional study — the research team administers the treatment under a controlled, IRB-approved protocol. Participation never happens outside that protocol.
- Substance
- Ketamine
- Status
- Recruiting now
- Conditions
- Depression, Chronic Low Back Pain
- Who can join
- Veterans only
- Where
- Michigan
- Run by
- VA Office of Research and Development
- Registry ID
- NCT06419439 ↗
How to join this study
Call or email the study team directly. You do not go through Psychedelic Vets — we just make the door easier to find.
Contact details as published by the sponsor, last verified 2025-12. People move on — if this doesn't reach anyone, check ClinicalTrials.gov.
What taking part involves
Initial phase: A small open-label, single arm pilot study (n=5) will be conducted to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. All participants in this open-label single arm pilot will receive the intervention (ketamine infusions followed by the brief behavioral intervention). There will be no control condition, randomization, or blinding.
Second phase: Intervention arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression.
Second phase: Control arm of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression.
Who can join
Listed as the research team wrote them. This is not a decision about you — only the study team can say whether you are eligible, and the only way to find out is to ask them.
What the study is looking for
- 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.
What would rule you out
- 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.
You enroll directly with the research team through their own official page and IRB-approved consent process. Psychedelic Vets does not run this study or collect any of your health information.
Study data is sourced from ClinicalTrials.gov (U.S. National Library of Medicine) and verified university/nonprofit sources. This page is educational and is not medical advice or an endorsement. Details can change — always confirm on the official page above. ← Back to all studies
