Pager-Assisted Smoking Cessation Treatment

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: smoking cessation counseling; Drug: Nicotine patch; Device: alphanumeric pager

• Registration Number: NCT01207310
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pager Arm	alphanumeric pager	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.
Control Arm	smoking cessation counseling	Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
Control Arm	Nicotine patch	Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
Pager Arm	smoking cessation counseling	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.
Pager Arm	Nicotine patch	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.

Primary Outcome Measures

Name	Time	Method
biologically-validated point prevalence smoking cessation	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States