Actively Recruiting
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Led by VA Office of Research and Development · Updated on 2025-12-18
44
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in Veterans who have chronic low back pain along with depression. These conditions are common causes of disability in the U.S., and Veterans with both conditions often face more challenges such as increased functional limitations and higher healthcare costs. The study is a Phase 2 pilot designed to test new combined approaches addressing both pain and mood symptoms simultaneously. The study has two phases. The first phase is an open-label pilot with five Veterans receiving four ketamine hydrochloride infusions administered intravenously twice weekly, followed by a brief narrative behavioral intervention. The second phase is a single-blind randomized controlled trial with 44 participants divided into two groups: one group receives ketamine infusions plus the brief behavioral intervention and minimally enhanced usual care (educational materials), while the control group receives only the educational materials. The ketamine dose is 0.5 mg/kg per infusion. Participants will be monitored through various assessments, including pain interference measured by the PROMIS Pain Interference Short Form, pain intensity by a numeric rating scale, and depression symptoms by the Quick Inventory of Depressive Symptoms. These evaluations occur about 8 to 10 days after randomization. Researchers will also collect participant feedback and assess the study's feasibility. The total study duration for participants is approximately four months, during which safety and adherence will be closely observed.
CONDITIONS
Brief Title
Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans with moderate to severe, high impact chronic low back pain (4/10 severity via NRS, present 3 months on most days)
- Pain interference with a PROMIS Pain Interference T-score of 60 or higher
- Current significant depressive symptoms with a QIDS-SR score of 11 or higher
- Medically stable without hospitalizations longer than 3 days in the past month
- No changes in pain or depression medications in the past 4 weeks
- No planned surgery, injections, hospitalizations, or new treatments for back pain or depression during the next four months except physical therapy or exercise
- Must have an adult available to drive participant home after ketamine treatments
You will not qualify if you...
- Cannot speak English due to the behavioral intervention language requirement
- Unable or unwilling to provide written informed consent (e.g., current delirium)
- Current psychotic symptoms or history of psychotic disorders such as schizophrenia or schizoaffective disorder
- Currently enrolled in another clinical trial for pain or depression
- Uncontrolled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure
- History of cirrhosis or unstable cardiac conditions (e.g., decompensated congestive heart failure)
- Liver or kidney lab values more than twice the upper limit of normal or abnormal thyroid hormone levels beyond set limits
- Positive pregnancy test or lack of birth control in Veterans who can become pregnant
- Known allergy to components of the ketamine injection
- Previous serious adverse reaction to ketamine
- Positive urine drug screen for non-prescribed substances (except cannabis) on infusion days
- Current or past ketamine abuse
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive four ketamine hydrochloride intravenous infusions administered twice weekly. After the infusions, participants in the open-label pilot and the intervention arm receive a brief narrative behavioral intervention to help reduce pain interference and improve mood.
4 infusion visits and 1 behavioral intervention visit
Duration - 8 to 10 days post randomization
Participants are assessed for pain interference, pain intensity, and depression symptoms about 8 to 10 days after randomization to evaluate the effects of the treatment.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105-2303
Actively Recruiting
Research Team
V
Victoria D Powell, MD
S
Sarah L Krein, PhD RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
3
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