E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Официальное название

Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Обзор

The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.

Вмешательства

• Поведенческое Telehealth Motivational Counseling
  At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15\~20 minutes each.
• Препарат Nicotine Replacement Product
  Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
• Устройство National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
  Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.

Первичные конечные точки

• Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) [Срок оценки: Up to Visit 5 (Day 56)]

Вторичные конечные точки (9)

• Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up [Срок оценки: Month 6]
• Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up [Срок оценки: From Visit 5 (Day 56) up to Month 6]
• Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) [Срок оценки: Baseline, Visit 5 (Day 56)]
• Change from Baseline in Self-Reported CPD at Month 6 [Срок оценки: Baseline, Month 6]
• Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5) [Срок оценки: Baseline, Visit 5 (Day 56)]
• Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up [Срок оценки: Baseline, Month 6]
• Number of Respiratory Symptoms Reported at Baseline [Срок оценки: Baseline]
• Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) [Срок оценки: Visit 5 (Day 56)]
• Number of Respiratory Symptoms Reported at Month 6 Follow-up [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Currently smokes 5 or more CPD
• Age ≥ 21 years
• Has a diagnosis of Opioid Use Disorder
• In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
• Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
• Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
• Own a mobile phone or have regular access to a mobile phone.
• Able to provide an additional contact to improve follow-up rates.

Критерии исключения

• Does not speak English or Spanish
• Are pregnant or breastfeeding
• Not able to provide consent
• Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
• Currently engaged in an attempt to quit CC smoking
• Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
• Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.

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

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• NYU Langone Health — New York
• Albert Einstein College of Medicine — The Bronx

Идентификаторы

NCT: NCT05722561 · 22-00661

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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