Behavioral Maintenance Treatment for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
研究概览
简要总结
Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. The investigators will also conduct secondary analyses of mediators and moderators of treatment response.
详细描述
400 adult smokers will be randomized. Our primary goal is to examine the effectiveness of a multi-factor maintenance treatment strategy in promoting longer-term smoking abstinence. All smokers will receive the same "Acute Phase Treatment" that combines nicotine patch, bupropion and intensive self-regulatory skills training. Nicotine patches will be provided for 8 weeks and bupropion and skills training will be provided for of 9 weeks. Participants will then enter a "Maintenance Treatment Phase" during which half (n=200) will receive three individualized relapse prevention training sessions spread over a 12 week period. They will also receive 12 weeks of self-administered RPT administered via written treatment modules. Finally, telephone counseling will be provided in conjunction with an Interactive Voice Response system (IVR) that will allow early detection of smoking "slips" and rapid response by treatment staff. The other half (n=200) will be assigned to a control condition that consists of three counselor-led sessions of "supportive therapy" spread over a 12 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (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
- •Healthy adult cigarette smokers smoking at least 10 cigarettes per day
排除标准
- •Currently pregnant
- •Currently breastfeeding
- •Currently diagnosed with a seizure disorder, major depression, liver disease, kidney disease, congestive heart failure
- •History of a seizure, seizure disorder, significant head trauma or central nervous system tumor
- •Family history of seizures
- •Currently using intravenous drugs
- •Currently using any drugs (marijuana, alcohol, cocaine, opiates, stimulants, etc.) on a daily basis
- •Currently using any over-the-counter stimulants and anorectics (diet pills)
- •Currently on bupropion (Wellbutrin, Wellbutrin SR) or other antidepressants, monoamine oxidase inhibitors, antipsychotics, benzodiazepines, theophylline, systemic steroids or levodopa
- •Currently on NRT or bupropion (Zyban)
- •Current or past diagnosis of anorexia nervosa or bulimia nervosa
- •Previous allergic response to bupropion or NRT
- •Previous failed quit attempt using NRT and bupropion in combination
研究组 & 干预措施
Open Label CBT and Pharmacotherapy
All study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label, this group received general supportive therapy delivered via four telephone calls made to participants over a 12-week period.
Behavioral: cognitive behavior therapy
All study participants received 8 weeks of cognitive and behavioral cessation and relapse prevention skills training (CBT) and nicotine patch therapy combined with 9 weeks of bupropion SR therapy. Following open-label treatment, half the participants received an additional 12 weeks of CBT that combined clinic-based skills training sessions, voicemail monitoring and telephone counseling
干预措施: cognitive behavior therapy (Behavioral)
结局指标
主要结局
expired-air carbon monoxide confirmed 7-day point prevalence smoking abstinence
时间窗: 52 weeks
expired-air carbon monoxide \< 10 ppm and self report of no smoking for 7 consecutive days prior to assessment
次要结局
- depression symptoms(52 weeks)
研究者
Joel D Killen
Principle Investigator
Stanford University