Bupropion and Weight Control for Smoking Cessation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 349
- 试验地点
- 1
- 主要终点
- Smoking Abstinence
研究概览
简要总结
The purpose of this study is to determine whether the addition of bupropion (Zyban) to cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
详细描述
Although rates of smoking have declined, the decrease in prevalence has been much less pronounced in women than in men, and women are particularly vulnerable to ongoing smoking-related morbidity and mortality. One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women, which is associated with poorer cessation outcome. We previously documented that cognitive behavior therapy to minimize weight concerns (CBT) was effective in promoting cessation and controlling weight gain among weight concerned women smokers. The current study is a randomized, double-blind, controlled trial to determine whether the addition of bupropion (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term abstinence. Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation, attenuates cessation-related weight gain (particularly in women), and relieves negative mood, which appears more common in weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions. In addition, we will determine the effects of these treatments on tobacco withdrawal, mood, and weight. Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Smoke at least 10 cigarettes per day
- •Report concern about cessation-related weight gain
- •Motivated to quit smoking
排除标准
- •Currently pregnant, lactating, or no medically approved method of contraception
- •Major medical problem
- •History of seizure disorder or head injury
- •Current or historical psychosis or bipolar disorder
- •History of alcohol or substance abuse within previous year
- •Current or historical eating disorder
- •Use of antidepressant medication, monoamine oxidase inhibitor or lithium with previous month
- •Multiple Drug Allergies
- •Current major depressive disorder
研究组 & 干预措施
Bupropion and Weight Concerns intervention
Bupropion SR and a weight concerns psychosocial intervention
干预措施: Bupropion (Drug)
Bupropion and Weight Concerns intervention
Bupropion SR and a weight concerns psychosocial intervention
干预措施: weight concerns intervention (Behavioral)
Placebo and Weight Concerns
A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
干预措施: Placebo (Drug)
Placebo and Weight Concerns
A matched placebo administered on same schedule as bupriopion and a weight concerns psychosocial intervention for smoking cesstion
干预措施: weight concerns intervention (Behavioral)
Bupropion and standard smoking cessation
Bupropion SR and a time and attention controlled smoking cessation intervention
干预措施: Bupropion (Drug)
Bupropion and standard smoking cessation
Bupropion SR and a time and attention controlled smoking cessation intervention
干预措施: smoking cessation intervention (Behavioral)
Placebo and standard smoking cessation
A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
干预措施: Placebo (Drug)
Placebo and standard smoking cessation
A matched placebo administered on same schedule as bupriopion and a time and attention controlled smoking cessation intervention
干预措施: smoking cessation intervention (Behavioral)
结局指标
主要结局
Smoking Abstinence
时间窗: 12 months
Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of \>15 micrograms/L were used to confirm non-smoking.
次要结局
未报告次要终点
研究者
Marsha Marcus
Professor of Psychiatry
University of Pittsburgh
