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Pager-Assisted Smoking Cessation Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Carmody, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01207310
First received: September 21, 2010
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Smoking Cessation
 Behavioral: smoking cessation counseling
Drug: nicotine replacement
Device: alphanumeric pager

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pager-Assisted Smoking Cessation Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • biologically-validated point prevalence smoking cessation [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    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:
  • continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months
Enrollment: 224
Study Start Date: May 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Behavioral counseling
Drug: nicotine replacement
8 weeks' worth of nicotine patches
Other Name: Nicoderm
Device: alphanumeric pager
therapeutic messages to be delivered for three months
Other Name: 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 Name: Behavioral counseling
Drug: nicotine replacement
8 weeks' worth of nicotine patches
Other Name: Nicoderm

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.

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207310

Locations
United States, California
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Timothy P Carmody, Ph.D University of California, San Francisco
  More Information

No publications provided

Responsible Party: Timothy Carmody, Health Sciences Clinical professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01207310     History of Changes
Other Study ID Numbers: 11RT0009
Study First Received: September 21, 2010
Last Updated: September 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
smoking
smoking of 10 cigarettes per day

ClinicalTrials.gov processed this record on March 03, 2015