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Идёт набор NCT06747871

Opioids, Low Nicotine Cigarettes, and Chronic Pain

Без фазы С лечением Chronic Pain Tobacco Use Opioid Substitution Treatment

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: Very Low Nicotine Cigarettes (VLNC), Normal Nicotine Cigarettes (NNC).
Кому может быть актуально
Состояния в реестре: Chronic Pain, Tobacco Use, Opioid Substitution Treatment. Базовые параметры: от 21 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain

Обзор

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).

Вмешательства

  • Поведенческое Very Low Nicotine Cigarettes (VLNC)
    Spectrum NRC 102/103 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 0.4 mg/g tobacco.
  • Поведенческое Normal Nicotine Cigarettes (NNC)
    Spectrum NRC 600/601 (nonmenthol/ menthol) cigarettes, which have a nicotine content of approximately 15.8 mg/g tobacco.

Первичные конечные точки

  • Nicotine Dependence as measured by the Fagerstrom Test of Cigarette Dependence (FTCD) [Срок оценки: Baseline and weekly during study cigarette use (4 weeks)]
  • Cigarettes per Day [Срок оценки: Baseline and weekly during study cigarette use (4 weeks)]
  • Pain as measured by the Brief Pain Inventory (BPI) [Срок оценки: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Mechanical Hyperalgesia [Срок оценки: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Smoking Withdrawal as measured by the Minnesota Withdrawal Scale (MNWS) [Срок оценки: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Cigarette Craving as measured by the Questionnaire of Smoking Urges-Brief (QSU-B) [Срок оценки: Baseline, during abstinence sessions, and at weekly visits during study cigarette use (4 weeks)]
  • Cigarette Purchase Task - demand intensity [Срок оценки: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Cigarette Purchase Task - Omax [Срок оценки: Weekly visits 1 and 5 during study cigarette use (4 weeks), and during abstinence sessions]
  • Pain-Smoking Associations as measured by Ecological Momentary Assessment (EMA) [Срок оценки: Baseline, weeks 1 and 4 of study cigarette use]
  • Buprenorphine-smoking associations as measured by Ecological Momentary Assessment (EMA) - smoking frequency [Срок оценки: Baseline, weeks 1 and 4 of study cigarette use]
Вторичные конечные точки (4)
  • Number of participants willing to Quit Smoking [Срок оценки: post-intervention, after 24 hrs abstinence]
  • Smoking abstinence self-efficacy as measured by the Self-Efficacy Questionnaire (SEQ) [Срок оценки: Weekly visits 1 and 5]
  • Pain and Smoking Inventory (PSI) [Срок оценки: Weekly visits 1 and 5]
  • Barriers to Quitting Smoking in Substance Abuse Treatment (BSQ-SAT) [Срок оценки: Weekly visits 1 and 5]

Критерии участия

Критерии включения

  • Aged 21+ years who smoke cigarettes daily
  • Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
  • Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
  • Self-report smoking at least 10 cigarettes/day
  • Expired breath carbon monoxide (CO) level >8 ppm
  • Have a smartphone capable of running software for ecological momentary assessment
  • Open to exploring the possibility of quitting smoking

Критерии исключения

  • Pain specifically due to cancer
  • Other significant health problems
  • Major surgery within the past 6 months or planned surgery within the timeframe of the study
  • Current disability litigation
  • Use of electronic cigarettes or other non-cigarette tobacco products > 9 of the past 30 days
  • Current use of nicotine replacement therapy or other cessation treatment
  • Current daily or near-daily cannabis use
  • History of psychotic disorder
  • Acute suicidality or current unstable psychiatric disorder
  • Positive pregnancy test
  • Actively seeking smoking cessation treatment

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

США · 1 центр
  • North Pavilion — Durham

Идентификаторы

NCT: NCT06747871 · Pro00116478 · 1R34DA060477-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗