Tailored Tobacco Intervention
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Tobacco use
研究概览
简要总结
The project is designed to examine the effectiveness of strategies to increase access to treatment for tobacco use and dependence among rural Veteran smokers. In addition, it will examine whether tailored treatment that is designed to address common comorbid conditions that are related to cigarette smoking enhances success with quitting relative to enhanced standard of care. The investigators hypothesize that participants assigned to the tailored tobacco cessation intervention will report greater cessation rates at six months. The investigators also anticipate more favorable outcomes on measures of depressive symptoms, alcohol use, and body weight.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veteran status
- •18 + years of age
- •Smoke cigarettes on at least a daily basis
- •Receive primary care from the Iowa City VA Health Care System or an affiliated Community-based Outpatient Clinic (CBOC)
- •Live in a non-metropolitan area (based on Rural-Urban Commuting Area Codes (RUCA) codes)
- •Be willing to make an attempt to quit smoking in the next 30 days
- •Be capable of providing informed consent
- •Have access to a telephone (land line or cell phone)
- •Have a stable residence
排除标准
- •Planning to move within the next 12 months
- •Presence of a terminal illness
- •Pregnancy
- •Unstable psychiatric disorder (e.g., acute psychosis)
- •Currently pregnant
- •Incarcerated
- •Institutionalized
研究组 & 干预措施
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Nicotine replacement therapy - Transdermal nicotine patch (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Nicotine replacement therapy - Nicotine gum (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Nicotine replacement therapy - Nicotine lozenge (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Bupropion (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Varenicline (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + bupropion (Drug)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Tailored behavioral intervention (Behavioral)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Alcohol use risk reduction (Behavioral)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Behavioral activation for depressive symptoms (Behavioral)
Tailored intervention
Participants will receive a combined behavioral and pharmacological intervention. The behavioral component will consist of a six-session cognitive behavioral telephone intervention combined with supplemental treatment modules to address common issues (symptoms of depression, weight gain, risky alcohol use) associated with cigarette smoking based on eligibility and preference.
干预措施: Behavioral management of postcessation weight gain (Behavioral)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Nicotine replacement therapy - Transdermal nicotine patch (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Nicotine replacement therapy - Nicotine gum (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Nicotine replacement therapy - Nicotine lozenge (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Bupropion (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Varenicline (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Combination pharmacotherapy - Transdermal nicotine patch + bupropion (Drug)
Enhanced standard of care
Participants assigned to the enhanced standard of care condition will receive referral to their state tobacco quitline along with pharmacotherapy to assist with smoking cessation.
干预措施: Tobacco quitline referral (Behavioral)
结局指标
主要结局
Tobacco use
时间窗: Six-month follow-up
At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven and 30 days.
次要结局
- Alcohol use(Six-month follow-up)
- Depressive symptoms(Six-month follow-up)
- Body weight(Six-month follow-up)
- Physical Activity(Six-month follow-up)
- Dietary intake(Six-month follow-up)
研究者
Mark Vander Weg
Associate Professor of Internal Medicine
University of Iowa