Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depr… (NCT06419439) | Clinical Trial Compass
RecruitingPhase 2
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
United States44 participantsStarted 2025-12-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cardi…
What they're measuring
1
Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)