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临床试验/NCT00618943
NCT00618943已完成3 期

Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

University of California, San Francisco6 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
6
主要终点
7 day point prevalence of cigarette abstinence

研究概览

简要总结

This research aims to identify efficacious strategies for treating tobacco dependence among adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a significant public health issue with 23% of high school students reporting smoking a cigarette in the past month1. Smoking rates are two to four times higher among adolescents with psychiatric disorders such as attention deficit disorders, conduct disorder, depression, anxiety disorders, and alcohol and illicit drug dependencies2-4.

Empirical investigations of adolescent tobacco treatment interventions number less than 50 with many of the studies criticized for methodological problems (i.e., follow up < 6 months, poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal successes; however, promising interventions include stage-based, cognitive behavioral (CBT), and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation interventions for this complex group be designed to assist smokers at all stages of readiness through the quitting process. A stepped care approach has the potential of matching more intensive services to those ready for and in need of greater treatment. Interventions delivered in health care settings have the appeal of broad reach.

The primary specific aims of this research are to evaluate, in a randomized clinical trial (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents recruited from outpatient psychiatry settings. To our knowledge, this would be the first study to examine outpatient psychiatry settings for treating tobacco dependence in adolescents. The stepped care intervention combines expert-system contacts, individual CBT sessions, and 12-weeks of nicotine replacement therapy (NRT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • receiving active outpatient psychiatric care
  • report smoking at least 1 cigarette in the previous 30 days and at least 100 cigarettes in their lifetime
  • Other inclusion criteria are: no plan to relocate outside of the greater San Francisco Bay Area in the next 12 months and telephone access for scheduling follow up assessments.

排除标准

  • cognitive impairment precluding ability to participate
  • non-English speaking
  • currently engaged in tobacco treatment
  • Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to assent to study participation

结局指标

主要结局

7 day point prevalence of cigarette abstinence

时间窗: 3, 6, 12 months post baseline

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jodi Prochaska

Associate Professor in Residence

University of California, San Francisco

研究点 (6)

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