Pager-Assisted Smoking Cessation Treatment (Pager)

October 29, 2017 updated by: Timothy Carmody, University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • Behavioral counseling
Drug: Nicotine patch
8 weeks' worth of nicotine patches
Other Names:
  • Nicoderm
Device: alphanumeric pager
therapeutic messages to be delivered for three months
Other Names:
  • Pager-assisted text messaging
Active Comparator: Control Arm
Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches.
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
Other Names:
  • Behavioral counseling
Drug: Nicotine patch
8 weeks' worth of nicotine patches
Other Names:
  • Nicoderm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 12 months after enrollment
maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months
12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Timothy P Carmody, Ph.D, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Actual)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11RT0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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