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临床试验/NCT01207310
NCT01207310已完成不适用

Pager-Assisted Smoking Cessation Treatment

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2003年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Active Comparator

Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.

干预措施: smoking cessation counseling (Behavioral)

Control Arm

Active Comparator

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

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

Timothy Carmody

Health Sciences Clinical professor

University of California, San Francisco

研究点 (1)

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