Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06419439

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

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Veterans with moderate to severe chronic low back pain lasting at least 3 months and significant pain interference
  • Current significant depressive symptoms based on a standard depression questionnaire
  • 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 4 months except physical therapy or exercise
  • Must have an adult available to drive home after ketamine treatments
Not Eligible

You will not qualify if you...

  • Cannot speak English
  • Unable or unwilling to provide written informed consent
  • Current psychotic symptoms or history of psychotic disorders like schizophrenia
  • Currently enrolled in another clinical trial for pain or depression
  • Uncontrolled high blood pressure above specified levels
  • Known elevated intracranial pressure, cerebral aneurysm, or elevated eye pressure
  • History of liver cirrhosis or unstable heart condition
  • Abnormal lab values exceeding twice the normal limits for certain liver, kidney, or thyroid tests
  • Positive pregnancy test or no birth control in Veterans who can become pregnant
  • Allergy to ketamine injection ingredients
  • Previous serious adverse reaction to ketamine
  • Positive drug screen for non-prescribed substances (except cannabis) on infusion day
  • Current or past ketamine abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States, 48105-2303

Actively Recruiting

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Research Team

V

Victoria D Powell, MD

CONTACT

S

Sarah L Krein, PhD RN

CONTACT

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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