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

This pilot study (n=44), sponsored by the VA Office of Research and Development, aims to assess the feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioral intervention in veterans suffering from chronic low back pain (CLBP) and depression.

CLBP and depression are significant issues among veterans, often leading to functional limitations and reduced treatment success.

The study will be conducted in two phases. The initial phase will involve a small open-label single-arm pilot with five veterans to develop procedures and obtain participant feedback. The subsequent phase will be a single-blind, two-arm pilot feasibility randomized controlled trial (RCT) with 44 participants (22 per arm) to assess feasibility benchmarks and collect outcome data for a larger RCT.

Participants will receive either ketamine infusions followed by the brief behavioral intervention or minimally enhanced usual care alone. Outcome measures include pain interference, pain intensity, depression symptoms, feasibility benchmarks, adverse events, and psychological measures.

The study, expected to start in December 2025, will be conducted at the VA Ann Arbor Healthcare System in Michigan, United States.

Trial Details

Chronic low back pain (CLBP) and depression often co-occur and are major contributors to disability in the United States, particularly among veterans. This study aims to address the dual challenges of CLBP and depression by testing a novel intervention. It will be conducted in two phases: an initial open-label pilot involving a small group of veterans to assess feasibility and obtain feedback, followed by a larger single-blind randomized controlled trial (RCT) to evaluate effectiveness and feasibility benchmarks. The intervention combines ketamine infusions with a brief behavioural intervention, aiming to reduce pain interference and improve mood in participants.

NCT Number NCT06419439

Data attribution

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