Pager-Assisted Smoking Cessation Treatment
Overview
- Phase
- Not Applicable
- Intervention
- smoking cessation counseling
- Conditions
- Smoking Cessation
- Sponsor
- University of California, San Francisco
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- biologically-validated point prevalence smoking cessation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Timothy Carmody
Health Sciences Clinical professor
University of California, San Francisco
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: smoking cessation counseling
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.
Intervention: Nicotine patch
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.
Intervention: alphanumeric pager
Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
Intervention: smoking cessation counseling
Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
Intervention: Nicotine patch
Outcomes
Primary Outcomes
biologically-validated point prevalence smoking cessation
Time Frame: 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 Outcomes
- continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement(12 months after enrollment)