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NMDA Receptor Antagonist

Ketamine for Chronic Lower Back Pain and Depression

Phase 2

Waitlist Available

Led By Victoria D Powell, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Known elevated intracranial pressure, cerebral arterial aneurysm, or elevated intraocular pressure

Inability to speak English due to the narrative intervention being conducted in English

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 1-7 or weekly (whichever is more frequent); visit 8 (1 month follow up), visit 9 (3 month follow up)

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing if ketamine infusions followed by a brief behavioral intervention are feasible, acceptable, and safe for Veterans with chronic low back pain and depression."

Who is the study for?

This trial is for veterans who have long-term lower back pain paired with depression. It's a pilot study, which means it's an early test to see if the approach works well and is safe.

What is being tested?

The study tests ketamine infusions (a type of medication that can affect mood and pain) followed by a short counseling session. The goal is to see if this combo helps more than usual care or just talking about one's life story.

What are the potential side effects?

Ketamine can cause side effects like changes in blood pressure, nausea, dizziness, mood swings, or hallucinations. The severity varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran with chronic low back pain, it interferes with my daily life, and I feel significantly depressed.

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I haven't been hospitalized for 3 days or more in the last month.

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My pain or depression medication has been the same for the last 4 weeks.

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I don't plan any new treatments for back pain or depression except physical therapy.

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I have someone to drive me home after ketamine treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high pressure in my brain, aneurysm, or high eye pressure.

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I cannot participate because I do not speak English.

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I do not have a history of severe liver disease or unstable heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 1-7 or weekly (whichever is more frequent); visit 8 (1 month follow up), visit 9 (3 month follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 1-7 or weekly (whichever is more frequent); visit 8 (1 month follow up), visit 9 (3 month follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 1-7 or weekly (whichever is more frequent); visit 8 (1 month follow up), visit 9 (3 month follow up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Pain intensity (Numeric Rating Scale)

Other study objectives

Acceptability

Catastrophizing (Catastrophizing Subscale from the Coping Strategies Questionnaire (CSQ-CAT))

Cognitive Flexibility (Cognitive Flexibility Scale (CFS))

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Open label, single arm pilotExperimental Treatment2 Interventions

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 II: Intervention + Minimally Enhanced Usual CareExperimental Treatment3 Interventions

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 III: Minimally Enhanced Usual Care OnlyActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine hydrochloride

2022

Completed Phase 4

~40

0 / 8Eligibility criteria met