Pager-Assisted Smoking Cessation Treatment

Smoking Cessation Clinical Trial

— Pager  

Official title:

Pager-Assisted Smoking Cessation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207310
• Other study ID #: 11RT0009
• Status: Completed
• Phase: N/A
• First received: September 21, 2010
• Last updated: October 29, 2017
• Start date: May 2003
• Est. completion date: December 2005

Study information

• Verified date: October 2017
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• smoking cessation counseling
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9

Drug:
• Nicotine patch
8 weeks' worth of nicotine patches

Device:
• alphanumeric pager
therapeutic messages to be delivered for three months

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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