Smoking Termination Enhancement Project (STEP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
研究概览
简要总结
The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 65 years old
- •Capable of providing informed consent, attend all study visits and comply with the protocol
- •Daily smoker for at least one year and currently smoke an average of at least 10 cigarettes per day
- •Report a motivation to quit smoking in the next month of at least 5 on a 10-point scale
- •Score of 20 or greater on 16-item Anxiety Sensitivity Index
- •Physically inactive as defined as participating in moderate-intensity exercise less than 2 days/week (duration must be 30 minutes or less each time)
排除标准
- •Use of other tobacco products
- •General medical condition(s) that contraindicate exercise
- •Resting blood pressure of ≥ 160 systolic and/or 100 diastolic who are not receiving treatment for high blood pressure
- •Blood lipid levels ≥ 240 mg/dl with LDL-C ≥ 160 mg/dl or triglyceride levels ≥ 300 mg/dl (individuals receiving medical treatment for lipid abnormalities with lipid levels above the cut-offs will be eligible with physician written approval)
- •Body mass index ≥40
- •Currently suicidal or high suicide risk
- •Current or past psychotic disorders of any type, or comorbid psychiatric conditions that are relative or absolute contraindications to the use of any treatment option in the study protocol
- •Currently pregnant, planning on becoming pregnant in the next year, or current breastfeeding
- •Alcohol or drug dependence; abuse of depressants, dissociative anesthetics, hallucinogens, opioids, or cocaine within the last 6 months
- •Psychotherapy initiated within the past three months, or ongoing psychotherapy of any duration directed specifically toward the treatment of anxiety or mood disorder other than general supportive therapy
- •Current use of any psychotherapy or pharmacotherapy for smoking cessation not provided by the researchers, including Chantix, Zyban, Welbutrin and Nortriptyline.
研究组 & 干预措施
Standard Care plus Wellness Program
干预措施: Cognitive Behavioral Treatment (Behavioral)
Standard Care plus Wellness Program
干预措施: Nicotine Patch (Drug)
Standard Care plus Wellness Program
干预措施: Wellness Program (Behavioral)
Standard Care plus Exercise Program
干预措施: Cognitive Behavioral Treatment (Behavioral)
Standard Care plus Exercise Program
干预措施: Nicotine Patch (Drug)
Standard Care plus Exercise Program
干预措施: Aerobic Exercise (Behavioral)
结局指标
主要结局
Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day
时间窗: End of treatment (10 weeks post quit day) and 30-week follow-up
Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up
次要结局
未报告次要终点
研究者
Jasper Smits, Ph.D.
Principal Investigator
University of Texas at Austin