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

VA Office of Research and Development

Status and phase: Enrolling; Phase 2

Conditions: Chronic Low Back Pain; Depression

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06419439

NURP-001-23F

IK2CX002646-01A2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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44 participants in 3 patient groups

Open label, single arm pilot

Other group

Description:

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.

Treatment:

Drug: Ketamine hydrochloride

Behavioral: Brief narrative intervention

Intervention + Minimally Enhanced Usual Care

Experimental group

Description:

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.

Treatment:

Drug: Ketamine hydrochloride

Behavioral: Brief narrative intervention

Behavioral: Minimally Enhanced Usual Care

Minimally Enhanced Usual Care Only

Active Comparator group

Description:

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:

Drug: Ketamine hydrochloride

Behavioral: Minimally Enhanced Usual Care