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

NCT06419439 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: NURP-001-23FIK2CX002646-01A2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Depression; Chronic Low Back Pain

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

Outcome Measures

Primary Outcomes (1)

• Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)

  Pain interference, defined as the extent to which pain impedes enjoyment of and participation in life activities (including cognitive, social, recreational, and self-care activities), will be the primary outcome. Raw scores (range 6 - 30, higher scores indicating more interference) are normed to mean of general population (T-score 50; SD 10); higher T-scores indicate higher pain interference. Minimum clinically important change is 3.0 - 3.5 point reduction in the T-score.

  Visit 7 (8-10 days post randomization)

Secondary Outcomes (2)

• Pain intensity (Numeric Rating Scale)

  Visit 7 (8-10 days post randomization)

• Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) )

  Visit 7 (8-10 days post randomization)

Other Outcomes (19)

• Feasibility - Enrollment

  18 months from start of study

• Presence of adverse events (AE)s

  Visits 1-7 or weekly (whichever is more frequent); Visit 8 (1 month follow up), Visit 9 (3 month follow up)

• Pain Interference (PROMIS Short Form v1.1 Pain Interference 6b)

  Visit 1 (Baseline), Visit 5 (post ketamine pre randomization), Visit 8 (1 month follow up), Visit 9 (3 month follow up)

Study Arms (3)

Open label, single arm pilot

OTHER

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.

Drug: Ketamine hydrochloride; Behavioral: Brief narrative intervention

Intervention + Minimally Enhanced Usual Care

EXPERIMENTAL

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.

Drug: Ketamine hydrochloride; Behavioral: Minimally Enhanced Usual Care; Behavioral: Brief narrative intervention

Minimally Enhanced Usual Care Only

ACTIVE COMPARATOR

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.

Drug: Ketamine hydrochloride; Behavioral: Minimally Enhanced Usual Care

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.

Intervention + Minimally Enhanced Usual Care; Minimally Enhanced Usual Care Only; Open label, single arm pilot

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).

Also known as: Control

Intervention + Minimally Enhanced Usual Care; Minimally Enhanced Usual Care Only

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.

Also known as: Active/intervention

Intervention + Minimally Enhanced Usual Care; Open label, single arm pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105-2303, United States

RECRUITING

MeSH Terms

Conditions

Depression; Narrative Medicine; Low Back Pain; Recurrence; Bronchiolitis Obliterans Syndrome

Interventions

Ketamine; Exercise; Methods

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Narration; Communication; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• Victoria D Powell, MD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria D Powell, MD

CONTACT

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

Sarah L Krein, PhD RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the second phase only will be blinded to the arm (intervention+minimally enhanced usual care vs minimally enhanced usual care alone).
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This study will occur in two phases which will occur sequentially and have different designs. The initial phase is a single-arm open-label, nonrandomized, non-blinded pilot study (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The subsequent phase, informed by these findings, will consist 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.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 17, 2024
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)