Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Electronic Cigarette
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
干预措施: Telehealth Motivational Counseling (Behavioral)
Electronic Cigarette
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC).
干预措施: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). (Device)
Nicotine Replacement Therapy
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
干预措施: Telehealth Motivational Counseling (Behavioral)
Nicotine Replacement Therapy
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
干预措施: Nicotine Replacement Product (Drug)
结局指标
主要结局
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
时间窗: Up to Visit 5 (Day 56)
Verified by exhaled carbon-monoxide (eCO) level.
次要结局
- Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)(Baseline, Visit 5 (Day 56))
- Number of Respiratory Symptoms Reported at Month 6 Follow-up(Month 6)
- Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up(Baseline, Month 6)
- Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up(Month 6)
- Change from Baseline in Self-Reported CPD at Month 6(Baseline, Month 6)
- Number of Respiratory Symptoms Reported at Baseline(Baseline)
- Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)(Visit 5 (Day 56))
- Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up(From Visit 5 (Day 56) up to Month 6)
- Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)(Baseline, Visit 5 (Day 56))