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

NCT ID: NCT06419439

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2029-06-30

Brief Summary

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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.

Detailed Description

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Chronic low back pain (CLBP) and depression are top causes of disability in the United States. Veterans are more likely to have both; prevalence is increasing. When CLBP and depression occur together, patients report more functional limitations, unemployment, and higher healthcare spending, and treatment is less successful. Novel approaches simultaneously addressing pain interference and depression symptoms are needed.

This study will involve initial pilot feasibility testing of an intervention designed to help participants with chronic low back pain and depression both reduce pain interference and improve mood. This study will occur in two phases. The initial phase is a open-label single-arm pilot of the combined intervention (ketamine infusions followed by the brief behavioral intervention) in a small sample of Veterans (n=5). The objective is to develop and assess initial feasibility of study procedures and obtain participant feedback through semi-structured exit interviews. The second phase consists 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.

Conditions

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Chronic Low Back Pain Depression

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants in the second phase only will be blinded to the arm (intervention+minimally enhanced usual care vs minimally enhanced usual care alone).

Study Groups

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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.

Group Type OTHER

Ketamine hydrochloride

Intervention Type DRUG

Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.

Brief narrative intervention

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Ketamine hydrochloride

Intervention Type 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

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Ketamine hydrochloride

Intervention Type 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

Intervention Type 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).

Interventions

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Ketamine hydrochloride

Participants in Arms 1, 2, and 3 will receive four twice-weekly ketamine hydrochloride intravenous infusions dosed at 0.5mg/kg.

Intervention Type DRUG

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).

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Control Active/intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Victoria D Powell, MD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

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VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria D Powell, MD

Role: CONTACT

Phone: (734) 845-3072

Email: [email protected]

Sarah L Krein, PhD RN

Role: CONTACT

Phone: (734) 845-3621

Email: [email protected]

Facility Contacts

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Victoria D Powell, MD

Role: primary

Sarah L Krein, PhD RN

Role: backup

Other Identifiers

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IK2CX002646-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NURP-001-23F

Identifier Type: -

Identifier Source: org_study_id