Clinical TrialChronic PainKetamineKetamineKetamineRecruiting

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

Pilot sequential study (n=44 planned; initial n=5 open-label pilot) assessing feasibility, acceptability, and safety of four twice-weekly IV ketamine infusions (0.5 mg/kg) followed by a brief narrative intervention versus minimally enhanced usual care in Veterans with chronic low back pain and depression.

Target Enrollment
44 participants
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

This pilot evaluates feasibility, acceptability, and safety of ketamine infusions followed by a brief behavioural narrative intervention to reduce pain interference and improve mood in Veterans with chronic low back pain and comorbid depression.

The study occurs sequentially: an initial open-label single-arm pilot (n=5) to refine procedures and collect participant feedback, followed by a single-blind, two-arm pilot RCT (n=44, 22 per arm). All participants receive four twice-weekly IV ketamine infusions (0.5 mg/kg); after infusions participants are randomised to brief narrative intervention plus minimally enhanced usual care or to minimally enhanced usual care alone.

Outcomes include feasibility benchmarks, safety/tolerability, pain interference, depressive symptoms, and measures to inform sample-size calculations for a larger RCT.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Open-label pilot

experimental

Initial open-label single-arm pilot (n=5): ketamine infusions followed by brief narrative intervention.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice-weekly• 4 doses total

    Four IV infusions of ketamine 0.5 mg/kg.

  • Compound

    Brief narrative intervention delivered after ketamine infusions (pilot).

Intervention + MEUC

experimental

Second-phase experimental arm: all receive ketamine infusions then randomised to brief narrative intervention plus minimally enhanced usual care.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice-weekly• 4 doses total

    Four IV infusions of ketamine 0.5 mg/kg.

  • Compound

    Minimally Enhanced Usual Care: educational reading materials regarding chronic back pain and depression.

  • Compound

    Brief narrative intervention delivered after ketamine infusions.

Minimally Enhanced Usual Care Only

active comparator

Second-phase comparator arm: all receive ketamine infusions then randomised to minimally enhanced usual care only.

Interventions

  • Ketamine0.5 mg/kg
    via IV• twice-weekly• 4 doses total

    Four IV infusions of ketamine 0.5 mg/kg.

  • Compound

    Minimally Enhanced Usual Care: educational reading materials regarding chronic back pain and depression.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:\n* Veterans with self-report of moderate to severe, high impact chronic low back pain (defined as 4/10 in severity via NRS, present 3 months on most days) and associated pain interference (defined as T-score ≥60 on the PROMIS Pain Interference measure), and current significant depressive symptoms (defined as a score ≥11 on the Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR)).\n* Medically stable (no hospitalizations in the past month lasting 3 days).\n* No changes in pain or depression medication regimen in 4 weeks.\n* No planned surgery, injections, hospitalizations, or other new interventions for back pain (except for physical therapy or exercise) or depression during the next four months (study duration).\n* Participants must have an adult who can drive them home after the ketamine treatments.

Exclusion Criteria

  • Exclusion Criteria:\n* Inability to speak English due to the narrative intervention being conducted in English.\n* Inability or unwillingness to provide written informed consent (e.g. current delirium).\n* Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.\n* Currently participating in another clinical trial for pain or depression.\n* Current uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).\n* Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.\n* History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).\n* Any of the following lab values >2x upper limit of normal: alanine transaminase (ALT), aspartate transferase (AST), direct bilirubin, alkaline phosphatase, creatinine; thyroid stimulating hormone (TSH) <2x lower limit of normal or >2x upper limit of normal.\n* Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.\n* Known hypersensitivity to any excipient in the ketamine injection formulation.\n* Previously experienced serious adverse effects with ketamine.\n* On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine.\n* Current or previous abuse of ketamine.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment44 participants
  • Timeline
    Start: 2024-12-01
    End: 2029-06-30
  • Compounds
    KetamineKetamineKetamine
  • Topic
    Chronic Pain

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor, Michigan, United States

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