Pager-Assisted Smoking Cessation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- biologically-validated point prevalence smoking cessation
研究概览
简要总结
The proposed study tests the efficacy of using pager-assisted messages combined with nicotine patches in facilitating smoking cessation and relapse prevention in a 2-arm randomized clinical trial. The hypothesis is that the proportion of biochemically-verified quitters at 3 and 12 months in the study arm randomized to receive therapeutic messages on alphanumeric pagers for 3 months along with individual smoking cessation counseling and nicotine patches will be greater that the proportion of biochemically-verified quitters who receive only individual smoking cessation counseling and nicotine patches.
详细描述
A total of 224 current smokers were enrolled in a randomized controlled smoking cessation trial. Participants were community-living adult smokers of ≥10 cigarettes per day during the pre-enrollment week who were interested in quitting and recruited from the local area by means of print, media, and online advertisements. To be eligible, they needed to be smoking 10 or more cigarettes per day, aged 18 or older, motivated to quit smoking, prepared to set a quit date, willing to use nicotine patches, and able to come to therapy sessions and be followed by telephone. Participants in the pager treatment were provided with alpha-numeric pagers free of charge for three months. Using specially-designed communication software, text messages were sent to participants aimed at facilitating motivation to quit, cessation strategies, and coping skills to maintain abstinence. Participants in both treatment groups were seen for two 60-minute sessions of standard smoking cessation counseling, and received three follow-up phone calls and two months of nicotine patches.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoking 10 or more cigarettes per day
- •aged 18 or older
- •motivated to quit smoking and prepared to set a quit date
- •willing to use nicotine patches
- •ability to come to therapy sessions and be followed by telephone
排除标准
- •individuals who are psychotic
- •severely depressed
- •organically brain impaired
- •actively abusing alcohol or other substances, and/or who have been drug dependent during the past six months
- •terminally ill
- •unable to be contacted by phone,currently using nicotine replacement or smoking cessation medications
- •those with contraindications to nicotine patches, female smokers who are pregnant or breastfeeding
研究组 & 干预措施
Pager Arm
Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.
干预措施: smoking cessation counseling (Behavioral)
Pager Arm
Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.
干预措施: Nicotine patch (Drug)
Pager Arm
Participants in the Pager Arm will be provided with alphanumeric pagers and will receive therapeutic messages on these pagers for 3 months in addition to individual smoking cessation counseling and nicotine patches.
干预措施: alphanumeric pager (Device)
Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
干预措施: smoking cessation counseling (Behavioral)
Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
干预措施: Nicotine patch (Drug)
结局指标
主要结局
biologically-validated point prevalence smoking cessation
时间窗: 12 months after enrollment
Abstinence from cigarettes "even a puff", other tobacco products and nicotine replacement for seven days at the 12 month follow-up date as validated by salivary cotinine less than 15 ng/ml
次要结局
- continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement(12 months after enrollment)
研究者
Timothy Carmody
Health Sciences Clinical professor
University of California, San Francisco
