Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Rate of Participant Retention
研究概览
简要总结
The purpose of this Pilot feasibility study is to find out the effect of different behavioral treatments along with different duration of a drug called varenicline, on smoking behavior and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that has been shown to help people quit smoking.
详细描述
Following the initial telephone screening, eligible participants will be scheduled for a screening evaluation session.
Following the screening evaluation, participants who pass the medical screening and meet all other inclusion criteria will be scheduled for their first assessment and then randomized to receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus facilitated extinction (EV + FE). The randomization list will be generated by the study statistician. It will be stratified by gender and will employ a variable block randomization that will guarantee that the arms are balanced when a given block is filled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •Smoke at least 10 cigarettes daily for the past year
- •Expired-air carbon monoxide (CO) > 8 ppm
- •Medically eligible to receive varenicline
- •Score at least a 5 on the Contemplation Ladder (Biener & Abrams 1991), a measure of motivation to quit smoking.
排除标准
- •Are pregnant or lactating
- •Have renal dysfunction
- •Have a history of seizures
- •Are medically at risk in the judgment of the study physician
- •Have ever used varenicline
- •Have used other smoking cessation medications within the past three months
- •Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic disorders)
- •Have substance use disorder as determined by a psychiatric screener (Mini International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).
- •We must limit the number of participants from the same street address to 1.
研究组 & 干预措施
Extended Varenicline + Facilitated Extinction
Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Varenicline (Drug)
Extended Varenicline + Facilitated Extinction
Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Counseling and Support Materials (Other)
Extended Varenicline + Facilitated Extinction
Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Laboratory Assessments (Other)
Standard Varenicline (SV)
Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Varenicline (Drug)
Standard Varenicline (SV)
Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Laboratory Assessments (Other)
Extended Varenicline (EV)
Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Varenicline (Drug)
Extended Varenicline (EV)
Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
干预措施: Laboratory Assessments (Other)
结局指标
主要结局
Rate of Participant Retention
时间窗: End of post treatment follow-up period of 3 months - approximately 28 weeks
Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
次要结局
- Mean Smoking Satisfaction Score Per Group(Across 4 pre-quit weeks)
- Mean Peak Craving Score Per Group(Across 4 pre-quit weeks)
- Client Satisfaction Questionnaire (CSQ) Results(One month post treatment - approximately 20 weeks)
- Rate of Intervention Adherence - Medication(One month post treatment - approximately 20 weeks)
- Average Intervention Adherence - Cigarettes Per Day (CPD)(During last week of treatment, week 16)