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Ketamine-assisted Integrative Treatment for Veterans With Chronic Low Back Pain and Comorbid Depression
Sponsor: VA Office of Research and Development
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-12-03
Completion Date
2029-06-30
Last Updated
2025-12-18
Healthy Volunteers
No
Conditions
Interventions
Ketamine hydrochloride
Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.
Minimally Enhanced Usual Care
Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression and will be provided to participants in arms 2 and 3 (pilot RCT).
Brief narrative intervention
Participants in Arm 1 (open label pilot) will receive the brief narrative intervention after four ketamine infusions. Participants in Arm 2 (those randomized after ketamine infusions are complete to the active arm of the pilot RCT) will receive the brief narrative intervention.
Locations (1)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States