Pager-Assisted Smoking Cessation Treatment (Pager)
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ClinicalTrials.gov Identifier: NCT01207310 |
Recruitment Status
:
Completed
First Posted
: September 22, 2010
Last Update Posted
: October 31, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Behavioral: smoking cessation counseling Drug: Nicotine patch Device: alphanumeric pager | Not Applicable |
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 |
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.
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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
|
- 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
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01207310
United States, California | |
San Francisco Veterans Affairs Medical Center | |
San Francisco, California, United States, 94121 |
Principal Investigator: | Timothy P Carmody, Ph.D | University of California, San Francisco |
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 Key Record Dates |
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 |