Smoking Cessation
Conditions
Keywords
smoking, smoking of 10 cigarettes per day
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.
Interventions
BEHAVIORALsmoking cessation counseling
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
DRUGNicotine patch
8 weeks' worth of nicotine patches
DEVICEalphanumeric pager
therapeutic messages to be delivered for three months
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed