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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (2)

• Pain intensity (Numeric Rating Scale) [Срок оценки: Visit 7 (8-10 days post randomization)]
• Depression (Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) ) [Срок оценки: Visit 7 (8-10 days post randomization)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• VA Ann Arbor Healthcare System, Ann Arbor, MI — Ann Arbor

Идентификаторы

NCT: NCT06419439 · NURP-001-23F · IK2CX002646-01A2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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