No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Other
Participants needed
44 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for veterans with chronic low back pain and depression. Participants will receive ketamine infusions along with a short behavioral intervention to help assess if this treatment is effective and safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am a veteran with moderate to severe chronic low back pain.
I have significant symptoms of depression.
I have been experiencing this pain for at least 3 months.
I have not been hospitalized in the past month.
I have not changed my pain or depression medication in 4 weeks.
I do not have planned surgeries or new interventions for back pain or depression in the next 4 months.
I have an adult who can drive me home after treatment.
You may not be able to join if
I cannot speak English.
I am unable or unwilling to give written consent.
I have current psychotic symptoms or a history of schizophrenia.
I am participating in another clinical trial for pain or depression.
I have uncontrolled high blood pressure.
I have a history of serious liver or heart problems.
I am pregnant or do not use birth control if capable of becoming pregnant.
I have previously experienced serious side effects from ketamine.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 dep…
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.
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