Pager-Assisted Smoking Cessation Treatment (Pager)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: smoking cessation counseling; Drug: Nicotine patch; Device: alphanumeric pager	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	224 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pager-Assisted Smoking Cessation Treatment
Study Start Date :	May 2003
Actual Primary Completion Date :	December 2005
Actual Study Completion Date :	December 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Behavioral counseling Drug: Nicotine patch; 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 patch; 8 weeks' worth of nicotine patches; Other Name: Nicoderm

Outcome Measures

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Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	September 22, 2010
Last Update Posted:	October 31, 2017
Last Verified:	October 2017

Keywords provided by Timothy Carmody, University of California, San Francisco:

smoking; smoking of 10 cigarettes per day

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action