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RECRUITING
NCT06419439
PHASE2

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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

Interventions

DRUG

Ketamine hydrochloride

Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.

BEHAVIORAL

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).

BEHAVIORAL

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