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Идёт набор NCT07080788

Oklahoma Study of Native American Pain Risk IV: Smoking Cessation and Pain

Без фазы С лечением Smoking Cessation Intervention Pain Smoking (Tobacco) Addiction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Smoking Cessation.
Кому может быть актуально
Состояния в реестре: Smoking Cessation Intervention, Pain, Smoking (Tobacco) Addiction. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Can Smoking Cessation Improve Physiological Markers of Chronic Pain Risk in Native American Smokers?: A Pilot Feasibility Study

Обзор

The goal of this pilot study is to assess whether 4-weeks of verified smoking abstinence following financial incentive treatment for smoking cessation improves physiological markers of chronic pain risk in adult Native American smokers. The main aims to answer are: 1. Determine study feasibility. 2. Obtain effect sizes for changes in pain amplification and pain inhibition in abstinent vs non-abstinent Native Americans. 3. Obtain effect sizes for variables in the conceptual model of the Native American smoking-pain relationship.

Подробное описание

Native Americans experience the highest rates of chronic pain of all U.S. racial/ethnic groups, and we have shown this disparity is partly explained by disrupted physiological pain regulation mechanisms, i.e., enhanced pain amplification and impaired pain inhibition. One unexplored variable that could disrupt these mechanisms in Native Americans is non-ceremonial tobacco smoking. Native Americans have the highest smoking rate in the U.S., and smoking is associated with disrupted pain regulation in non-Native American samples. Thus, there is a critical need to understand whether smoking contributes to NA pain risk.

There is high comorbidity between smoking and chronic pain, but it is also known that chronic pain patients who quit smoking have improved pain. This study aims to better understand the relationship between Native American smoking and chronic pain risk. It is believed that smoking increases chronic pain risk in pain-free Native Americans by increasing pain amplification and impairing pain inhibition, and smoking abstinence will reduce pain amplification and increase pain inhibition.

Вмешательства

  • Поведенческое Smoking Cessation
    Investigators will provide financial incentives for biochemically verified abstinence at 4 weeks following treatment. This incentive is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior.

Первичные конечные точки

  • Pain inhibition [Срок оценки: Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)]
  • Inhibition of pain-related spinal reflex [Срок оценки: Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)]
  • Allostatic load [Срок оценки: Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)]
  • Pain amplification [Срок оценки: Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)]
Вторичные конечные точки (1)
  • Temporal summation of pain [Срок оценки: Baseline (1 day prior to smoking cessation treatment allocation) and Post-Treatment (following 4 weeks of treatment + 4 weeks of verified smoking abstinence)]

Критерии участия

Критерии включения

  • Self-identify as Native American/American Indian
  • Currently daily smoker
  • Own a smartphone with a data plan
  • Ability to speak and read English

Критерии исключения

  • >18 years of age
  • Currently pregnant
  • Self-reported history of heart disease or heart attack
  • Angina, arrhythmias, hypertension, heart disease
  • Current chronic pain
  • Pepper allergy
  • Inability to speak English
  • Current psychosis (assessed by Psychosis Screening Questionnaire)
  • Serious cognitive impairment (assessed by <20 score on the Montreal Cognitive Assessment \[MoCA\])

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • University of Oklahoma - Schusterman Center — Tulsa

Идентификаторы

NCT: NCT07080788 · 18695

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗