Pager-Assisted Smoking Cessation Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pager-Assisted Smoking Cessation Treatment

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: smoking cessation counseling
* Drug: Nicotine patch
* Device: alphanumeric pager


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pager Arm<br>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. | Behavioral: smoking cessation counseling<br>* two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9<br>* Other names: Behavioral counseling;Drug: Nicotine patch<br>* 8 weeks' worth of nicotine patches<br>* Other names: Nicoderm;Device: alphanumeric pager<br>* therapeutic messages to be delivered for three months<br>* Other names: Pager-assisted text messaging;|
| Active Comparator: Control Arm<br>Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches. | Behavioral: smoking cessation counseling<br>* two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9<br>* Other names: Behavioral counseling;Drug: Nicotine patch<br>* 8 weeks' worth of nicotine patches<br>* Other names: Nicoderm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biologically-validated point prevalence smoking cessation | 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 | 12 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continuous abstinence from cigarettes even a puff, tobacco products and nicotine replacement | maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months | 12 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, smoking of 10 cigarettes per day