Comparison of Standard Versus Extended Nicotine Patch Therapy for Smoking Cessation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 2
- 主要终点
- Biochemically Verified 7-day Point Prevalence Abstinence
研究概览
简要总结
This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.
详细描述
Please see brief summary.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of descent between the ages of 18-65 who smokes at least 10 cigarettes/day and are seeking smoking cessation treatment.
- •Based on the medical history, physical and laboratory examination, premenopausal female subjects must consent to practice an effective form of contraception during study.
- •Following orientation by the research staff, subjects must sign written informed consent for all study procedures.
排除标准
- •Women who are pregnant, planning a pregnancy, or lactating.
- •Current medical problems for which TN is contraindicated including allergy to nicotine, uncontrolled hypertension, unstable angina, serious arrhythmia, heart attack or stroke within the past 6 months, liver and/or kidney failure in the last 6-months and current diabetes.
- •Current treatment of cancer or diagnosed with cancer in the past 6 months
- •Current DSM IV substance use disorders (dependence involving alcohol, cocaine, marijuana or stimulants, benzodiazepines).
- •Current use of TN or other forms of NRT.
- •Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, endogenous steroids, and antidepressants (including wellbutrin or bupropion).
研究组 & 干预措施
Extended Patch Treatment
Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions.
干预措施: 24-weeks of nicotine patch (Drug)
Standard Patch Treatment
Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.
干预措施: Standard Patch Treatment (Drug)
结局指标
主要结局
Biochemically Verified 7-day Point Prevalence Abstinence
时间窗: End of Treatment (week 24)
To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy.
次要结局
未报告次要终点