Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
研究概览
简要总结
In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently smokes 5 or more CPD
- •Willingness and ability to provide informed consent
- •Age of at least 21 years
- •Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
- •Interested in reducing 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
- •Is pregnant or breastfeeding
- •Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
- •Currently engaged in an attempt to quit CC
- •Change in dose of their psychotropic medication(s) in the last 30 days
- •Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
- •Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
结局指标
主要结局
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
时间窗: Up to Week 4
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
时间窗: Up to Week 8
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).
次要结局
- Self-Reported Percent Change in CPD from Baseline to Week 12(Baseline, Week 12)
- Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12(Up to Week 12)
- Self-Reported Percent Change in CPD from Baseline to Week 8(Baseline, Week 8)
- Change in American Thoracic Questionnaire Score from Baseline to Week 12(Baseline, Week 12)
- Change in Symptom Check Questionnaire Score from Baseline to Week 12(Baseline, Week 12)