RecruitingPhase 2ketamine

Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression

Sponsored by VA Office of Research and Development

NCT ID
NCT06419439
Target Enrollment
44 participants
Start Date
2025-12-03
Est. Completion
2029-06-30

About This Study

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.

Conditions Studied

Chronic Low Back PainDepression

Interventions

  • Ketamine hydrochloride
  • Minimally Enhanced Usual Care
  • Brief narrative intervention

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full 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 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.

Study Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Victoria D Powell, MD
CONTACT
(734) 845-3072Victoria.Powell2@va.gov
Sarah L Krein, PhD RN
CONTACT
(734) 845-3621Sarah.Krein@va.gov
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source