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New treatment option for Chronic Low Back Pain
Official title Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
ClinicalTrials.gov ID: NCT06419439
What this study is testing
What is Ketamine hydrochloride?
Ketamine hydrochloride is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for chronic low back pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Participants must have an adult who can drive them home after the ketamine treatments.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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 upper limit...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.