A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Biochemically-verified smoking abstinence
研究概览
简要总结
This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation.
详细描述
Participants will be recruited through newspaper and internet advertisements, advertisements on public transportation, community centers and community based organizations. All recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The first contact with potential participant will be by telephone interview to assess for eligibility of participant. Participants who meet eligibility criteria will be invited to an orientation meeting where a breath carbon monoxide sample will be obtained. Women participant of childbearing potential will have a pregnancy test administered.
Participants will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation for behavioral and cognitive strategies. the RT condition will control for the therapeutic contact received by those in the E+WT condition and will consist of the development, application, modification, and repeated practice of individualized relaxation techniques (e.g. breathing exercises, imagery).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women at least 19 years of age
- •Reports smoking at least 10 cigarettes per day
- •Must have expired breath carbon monoxide reading of at least eight parts per million
- •Report the intention to quit smoking
- •Reside in the Birmingham area with no plan to relocate outside of the area in the next six months
- •Have access to a telephone for scheduling follow up assessments
排除标准
- •Inability to speak English
- •Presence of a condition that contraindicates use of transdermal nicotine patch (i.e. angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives, serious skin disorders, and current pregnancy or breast feeding)
- •Presence of conditions that might interfere with compliance with protocol or greatly complicate treatment (i.e. current alcohol or other substance dependence, dementia, psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any disease acutely life-threatening or so severe that the participant cannot comply with the protocol)
- •Concurrent participation in a formal treatment program for smoking cessation
- •Current use of any pharmacotherapy for smoking cessation
研究组 & 干预措施
Withdrawal regulation training
Withdrawal coping skills
干预措施: Withdrawal regulation training (Behavioral)
Relaxation training
Relaxation skills instruction
干预措施: Relaxation training (Behavioral)
结局指标
主要结局
Biochemically-verified smoking abstinence
时间窗: 3 months after end-of-treatment
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
Biochemically verified smoking abstinence
时间窗: 2 months after end-of-treatment
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
次要结局
- Withdrawal symptoms(3 months after end-of-treament)
- Withdrawal symptoms(2 months after end-of-treatment)
研究者
Peter Hendricks
Principal Investigator
University of Alabama at Birmingham