跳至主要内容
临床试验/NCT00156702
NCT00156702已完成1 期

Researching the Youth Smoking Experience

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
2
主要终点
Smoking rates

研究概览

简要总结

The primary hypothesis of this pilot study is that dependence can be prevented in adolescents who smoke, but who are not yet dependent. With this study, we seek to develop and test the feasibility and provide controlled comparisons of two brief smoking dependence-prevention interventions: motivational interviewing with feedback versus a video control. Forty adolescents between the ages of 12 and 18 will be enrolled. The evaluation and dependence-prevention phases will occur during a single 3- to 4-hour session, and the 30-45 minute follow-up sessions will take place approximately one month, three months, six months, and one year after the completion of the evaluation and dependence prevention phases.

详细描述

III. Hypothesis: The primary hypothesis of this pilot study is that dependence can be prevented in adolescents who smoke, but who are not yet dependent. With this study, we seek to develop and test the feasibility and provide controlled comparisons of two brief smoking dependence-prevention interventions. Additional analyses will be conducted to determine which, if any, demographic, psychological, personality, behavioral, or family characteristics predict which adolescents respond best to dependence-prevention interventions, though no clear a priori predictions can be made.

IV. Specific Aims: The primary aim of this pilot study is to prevent dependence in adolescent smokers, who are at great risk for nicotine dependence and tobacco-related disease. Nicotine dependence is a disease that begins in children and adolescents: approximately three quarters of adult tobacco users (i.e., cigarette and cigar smokers and users of smokeless tobacco, or SLT) report that their first tobacco use occurred when they were 11-17 years old (USDHHS, 1994a; 1994b; Riley et al., 1996). Moreover, the earlier a person starts smoking, the higher their eventual daily cigarette consumption (Taoli and Wydner, 1991), and the greater their risk of dying from a smoking-related disease (USDHHS, 1989). Because smoking begins in adolescents and because young tobacco users are at the greatest risk for progressing to dependence and dying of smoking-related disease, adolescent smokers would benefit immensely from effective tobacco dependence prevention.

VI. Preliminary Progress/Data Report: This project involves an evaluation phase, including laboratory measurement of tobacco's effects, a dependence-prevention phase, and a follow-up phase. Because the laboratory measurement is critical to the success of all phases (data generated in the laboratory phase are used in the intervention and thus influence the follow-up), this preliminary data section will focus on laboratory research.

The Clinical Behavioral Pharmacology Laboratory (CBPL; T. Eissenberg, Director) has been a site for safe and ethical studies of tobacco use in adults (e.g., Eissenberg et al., 1999; Buchhalter and Eissenberg, 2000; Buchhalter et al., 2001; Breland et al., in press). In addition, Dr. Eissenberg initiated a discussion on how to conduct safe and ethical tobacco research in adolescents: in 2000, he planned and chaired a symposium entitled "Ethical and Practical Challenges in Tobacco Research with Children" at the 6th Annual Meeting of the Society for Research on Nicotine and Tobacco (Eissenberg, 2000; see also Eissenberg and Balster, 2002). He has also been involved in several laboratory studies involving young adults (e.g., Gire and Eissenberg, 2001) and adolescents (Zack et al., 2001; Corrigall et al., 2000).

Progress on the current project has included the establishment and maintenance of an adolescent clinical lab facility for direct observation of young smokers and for testing brief-intervention strategies in a controlled setting; recruitment of scientific and clinical staff; development of subject recruitment procedures; engagement of local school personnel in the recruiting process, utilization of advertising on city buses to aid recruitment, development and pilot testing of the brief interventions; successful completion of 17 subject baseline lab sessions and 8 telephone follow-at 1 month, 3 at 3 month, 1 visit at 6 months, 1 phone contact at 9 month, and 1 visit at 12 month. Four participants have been lost to follow-up.

研究设计

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

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be healthy, between the ages of 12 and 18 years of age, and be current smokers (defined as at least one cigarette in the last week, according to participant self-report).

排除标准

  • In order to ensure that smokers are not yet dependent, adolescents who have smoked more than 10 cigarettes per day each day of the last week will be excluded. Other exclusionary criteria include: history of or current specific health concerns, including cardiovascular disease, pregnancy or current breast feeding.

结局指标

主要结局

Smoking rates

次要结局

  • Smoking and quitting motivation

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Researching the Youth Smoking Experience | 临床试验