Pager-Assisted Smoking Cessation Treatment (Pager)
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| ClinicalTrials.gov Identifier: NCT01207310 |
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Recruitment Status :
Completed
First Posted : September 22, 2010
Last Update Posted : October 31, 2017
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Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
Timothy Carmody, University of California, San Francisco
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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Active Comparator: Control Arm
Participants in the Control Arm will receive 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 |
Primary Outcome Measures :
- 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 :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
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
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 |
| 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:
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smoking smoking of 10 cigarettes per day |
Additional relevant MeSH terms:
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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 |