NCT06419439

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed. This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists of a single-blind, two-arm, pilot feasibility randomized controlled trial (RCT) (n=44, 22 per arm) which will (a) assess feasibility benchmarks and (b) collect outcome data that will be used to calculate sample size to power a larger RCT.

Conditions

• Chronic Low Back Pain
• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-12-01
• Completion: 2029-06-30
• First posted: 2024-05-17
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study