Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure
研究概览
简要总结
The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.
详细描述
This 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (AW) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. Neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. We expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. We postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. We expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. Because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.
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
- 13 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •More than 100 lbs
- •IQ greater than 80
- •General good health
- •Not pregnant
- •Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime
- •Smokers: Smoke more than 6 cigarettes per day for at least 6 months
排除标准
- •Cardiac, Central Nervous System (CNS) or severe psychiatric disorder
- •Psychoactive medications (including nicotine replacement)
- •Substance use disorder
研究组 & 干预措施
Active medication
300mg bupropion HCL
干预措施: Bupropion (Drug)
Placebo
Placebo pill
干预措施: Bupropion (Drug)
结局指标
主要结局
Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure
时间窗: 7 weeks
次要结局
- Reduction of smoking-related urges and cravings.(7 weeks)
