Maintaining Nonsmoking: Older Smokers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 403
- 试验地点
- 1
- 主要终点
- Participants Abstinent From Cigarettes
研究概览
简要总结
The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.
详细描述
The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. Participants were 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Brief Treatment
Pharmacological Treatment - Subjects received 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment (NRT)
Brief Counseling - The counseling intervention consisted of five 90-minute group meetings.
There was no further treatment during Weeks 12-52.
干预措施: Nicotine polacrilex, Bupropion (Drug)
Extended NRT
Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition would continue receiving NRT for up to 52 weeks. Subjects in this condition would be encouraged to continue NRT through Week 24. If a subject terminated NRT and resumed smoking, before Week 50, would be instructed to set a quit date and resume NRT.
Counseling Treatment - This is identical to the Brief Counseling described above.
干预措施: Nicotine polacrilex, Bupropion (Drug)
Tailored/No Extended NRT
This condition was identical to the Tailored/NRT condition except that no NRT was available after completion of the Brief Treatment.
干预措施: Nicotine polacrilex, Bupropion (Drug)
Extended Tailored Counseling + NRT
Tailored Counseling Treatment- The primary goal of the extended treatment was to prevent relapse. Secondary goal was to encourage initiation of abstinence for those who have not attained it by Week 12, and re-initiation of abstinence after slips. Subjects would participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session would occur at Week 10. Additional sessions would be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session would be 20-30 minutes long. Between sessions subjects would be contacted by phone for brief check-ins (5-10 minutes).
干预措施: Nicotine polacrilex, Bupropion (Drug)
结局指标
主要结局
Participants Abstinent From Cigarettes
时间窗: Two years
Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104
次要结局
未报告次要终点