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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT06419439
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketamine hydrochloride — DRUG
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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 Dates

Start date
Dec 3, 2025
Status verified
Dec 2025
Primary completion
Dec 1, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Other: Open label, single arm pilot
    Initial phase: A small open-label, single arm pilot study (n=5) will be conducted to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. All participants in this open-label single arm pilot will receive the intervention (ketamine infusions followed by the brief behavioral intervention). There will be no control condition, randomization, or blinding.
  • Experimental: Intervention + Minimally Enhanced Usual Care
    Second phase: Intervention arm 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. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression.
  • Active Comparator: Minimally Enhanced Usual Care Only
    Second phase: Control arm 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. Minimally Enhanced Usual Care will consist of educational reading materials regarding chronic back pain and depression.

Primary Outcome Measure

Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b) [ Time Frame: Visit 7 (8-10 days post randomization) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Victoria D Powell, MD
[email protected]
734-845-3072
Sarah L Krein, PhD RN
[email protected]
(734) 845-3621
Victoria D Powell, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Ann Arbor Healthcare System, Ann Arbor, MI· Ann Arbor, MI

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