Smoking CessationPagerNCT01207310
Pager-Assisted Smoking Cessation Treatment
A study testing smoking cessation counseling, Nicotine patch and alphanumeric pager in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- smoking cessation counseling, Nicotine patch and alphanumeric pager
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- smoking cessation counseling, Nicotine patch, alphanumeric pager
- Keywords
- smoking, smoking of 10 cigarettes per day
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation counselingBehavioural
Also called Behavioral counseling
two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
Nicotine patchDrug
Also called Nicoderm
8 weeks' worth of nicotine patches
alphanumeric pagerDevice
Also called Pager-assisted text messaging
therapeutic messages to be delivered for three months
| Study group | Role | What they receive |
|---|---|---|
| Pager Arm | Experimental | 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. Receives: Behavioral: smoking cessation counseling; Drug: Nicotine patch; Device: alphanumeric pager |
| Control Arm | Active comparator | Participants in the Control Arm will receive individual smoking cessation counseling and nicotine patches. Receives: Behavioral: smoking cessation counseling; Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
biologically-validated point prevalence smoking cessation
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
Measured: 12 months after enrollment
Secondary outcomes (1)
continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement
maintained cessation from smoking, biologically-validated by repeated measures of salivary cotinine less than 15 ng/ml at 12 months
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startMay 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Carmody, University of California, San Francisco
- Investigators
- Timothy P Carmody, Ph.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207310
- Sponsor's protocol ID
- 11RT0009
- Acronym
- Pager
- Status last verified
- Oct 2017
- First submitted
- 21 Sep 2010
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pager-Assisted Smoking Cessation Treatment
- ClinicalTrials.gov ID
- NCT01207310
- Acronym / sponsor ID
- Pager / 11RT0009
- Conditions
- Smoking Cessation
- Keywords
- smoking, smoking of 10 cigarettes per day
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 22 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pager Arm | Experimental | Behavioral: smoking cessation counseling, Drug: Nicotine patch, Device: alphanumeric pagerParticipants 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. |
| Control Arm | Active comparator | Behavioral: smoking cessation counseling, Drug: Nicotine patchParticipants in the Control Arm will receive individual smoking cessation counseling and nicotine patches. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking cessation counselingAlso: Behavioral counselingtwo 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9 | Behavioural | Control Arm, Pager Arm |
| Nicotine patchAlso: Nicoderm8 weeks' worth of nicotine patches | Drug | Control Arm, Pager Arm |
| alphanumeric pagerAlso: Pager-assisted text messagingtherapeutic messages to be delivered for three months | Device | Pager Arm |
Primary outcome
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
1 secondary outcome
continuous abstinence from cigarettes "even a puff", tobacco products and nicotine replacement
Time frame: 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy P Carmody, Ph.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smoking cessation counseling, Nicotine patch and alphanumeric pager in people with Smoking Cessation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biologically-validated point prevalence smoking cessation (time frame: 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2017.