Recruiting
Phase 2

Ketamine

Sponsor:

VA Office of Research and Development

Code:

NCT06419439

Conditions

Chronic Low Back Pain

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketamine hydrochloride

Minimally Enhanced Usual Care

Brief narrative intervention

Study Details

Brief 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.

Conditions

Chronic Low Back Pain

Depression

Study ID

NCT06419439

Start date

Dec 3, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).
  • Medically stable (no hospitalizations in the past month lasting 3 days).
  • No changes in pain or depression medication regimen in 4 weeks.
  • 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).
  • Participants must have an adult who can drive them home after the ketamine treatments.

Exclusion Criteria:

  • Inability to speak English due to the narrative intervention being conducted in English.
  • Inability or unwillingness to provide written informed consent (e.g. current delirium).
  • Current psychotic symptoms, or history of schizophrenia, schizoaffective disorder, and other psychotic disorder.
  • Currently participating in another clinical trial for pain or depression.
  • Current uncontrolled hypertension (defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
  • Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure.
  • History of cirrhosis or unstable cardiac condition (e.g., decompensated congestive heart failure).
  • 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.
  • Positive urine pregnancy test or lack of birth control method in Veterans of childbearing potential.
  • Known hypersensitivity to any excipient in the ketamine injection formulation.
  • Previously experienced serious adverse effects with ketamine.
  • On day of ketamine infusions, a urine drug screen positive for non-prescribed substances(s) (except cannabis) will exclude a participant from receiving ketamine
  • Current or previous abuse of ketamine.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Ketamine hydrochloride

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

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Victoria D Powell, MD

(734) 845-3072Victoria.Powell2@va.gov

Sarah L Krein, PhD RN

(734) 845-3621Sarah.Krein@va.gov

Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Recruiting

Ann Arbor, Michigan, United States, 48105-2303

Contacts

Victoria D Powell, MD

734-845-3072Victoria.Powell2@va.gov

Sarah L Krein, PhD RN

(734) 845-3621Sarah.Krein@va.gov

Principal Investigator:

Victoria D Powell, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Keywords

  • Feasibility Studies
  • Pilot Projects
  • Randomized Controlled Trials
  • Clinical trials
  • Psychosocial Intervention
  • Narrative Medicine
  • Narrative Therapy
  • Ketamine
  • Ketamine, therapeutic use
  • Veterans
  • Veterans, Research Subjects
  • Low Back Pain, Recurrent/Chronic
  • Depression
  • Hallucinogens, Therapeutic Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-12-18.