跳至主要内容
临床试验/NCT00248118
NCT00248118终止2 期

Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

300mg bupropion HCL

干预措施: Bupropion (Drug)

Placebo

Placebo Comparator

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)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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