Smoking CessationPhase 3NCT01287377
Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
A Phase 3 study testing Telephone Counseling and Nicotine Patches in people with Smoking Cessation, run by University of California, San Diego at 1 site in United States.
Trial summary
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to: 1. See if subjects will use pre-cessation nicotine patches. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Telephone Counseling and Nicotine Patches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >= 18 years old
- Daily smoker
- >=10 cigarettes per day
- Ready to quit within one month
- First time quitline caller
- Valid phone number
Show all 10Show fewer
- Valid address (no P.O. boxes)
- California resident
- Agree to participate in study and evaluation
- English speaking
Who cannot join
- Uses other form of tobacco
- Plan to use quitting aids other than nicotine patch
- Has any of the following conditions:
- Severe allergy to adhesive tape
- Arrhythmia
- Angina
Show all 11Show fewer
- Heart attack within last 6 months
- Stroke within last 6 months
- Uncontrolled high blood pressure
- Insulin-dependent diabetes
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92111
About this study
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to:
- See if subjects will use pre-cessation nicotine patches.
- See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- See if sending 2-weeks' worth of patches is helpful to the quitting process.
Read the detailed description
Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo control. Recently a number of studies have examined the use of patches prior to quitting. A meta-analysis indicates that such pre-cessation treatment with nicotine patches doubles the odds of quitting, compared to starting patch treatment on the quit day, as is traditionally done.
The proposed study would look at both pre-cessation treatment with nicotine patches as well as looking to see if sending clients nicotine patches is helpful in their quitting process. The rationale for pre-cessation treatment with patches is that using patches in this manner would make it easier to quit smoking because it may: reduce the reinforcing effects of cigarette smoking, thus helping to overcome conditioned behavior; reduce the need for inhaled nicotine as smokers naturally decrease their cigarette consumption to titrate the level of nicotine in their system; and/or increase compliance with patch use in the quitting phase.
The rationale for sending nicotine patches is that when callers must go and get the patches on their own it creates a barrier to their quitting so that sending nicotine patches directly to a callers' home would make it easier for them to stay on task and quit. This pilot will allow us to test the feasibility of sending pre-treatment nicotine patches and to examine the effects associated with the pre-cessation treatment phase.
This pilot project has the following specific aims, to examine whether:
- Subjects will use pre-cessation nicotine patches.
- Subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- Pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- Sending 2-weeks' worth of patches is helpful to the quitting process.
Results will add to the theoretical understanding of behavior change from which new, effective interventions can spring.
- Conditions
- Smoking Cessation
- Being tested
- Telephone Counseling, Nicotine Patches
- Keywords
- tobacco cessation, smoking cessation, nicotine, counseling, telephone, self-help, smoking abstinence, tobacco use disorder, nicotine replacement therapy
- Medical subject headings
- Smoking Cessation, Tobacco Use Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingBehavioural
Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
Nicotine PatchesDrug
Also called Habitrol
Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).
For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Patch and Telephone Counseling | Experimental | Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. Receives: Behavioral: Telephone Counseling; Drug: Nicotine Patches |
| Post-Patch and Telephone Counseling | Active comparator | Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date.
Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. Receives: Behavioral: Telephone Counseling; Drug: Nicotine Patches |
| Telephone Counseling and no patches sent | Active comparator | Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. Receives: Behavioral: Telephone Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Have Not Used Tobacco in the Past 30 Days
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
Measured: 2-months post enrollment
Secondary outcomes (1)
Number of Participants With Serious Quit Attempts
A serious quit attempt is considered is a quit attempt that last more than 24 hours
Measured: 2-months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionMay 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Hong Zhu, University of California, San Diego
- Investigators
- Shu-Hong Zhu, Ph.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287377
- Sponsor's protocol ID
- 100683
- Status last verified
- Feb 2020
- First submitted
- 28 Jan 2011
- Last updated
- 13 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation With the Nicotine Patch: A Pilot Study of Patch Messaging
- ClinicalTrials.gov ID
- NCT01287377
- Acronym / sponsor ID
- 100683
- Conditions
- Smoking Cessation
- Keywords
- tobacco cessation, smoking cessation, nicotine, counseling, telephone, self-help, smoking abstinence, tobacco use disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to:
- See if subjects will use pre-cessation nicotine patches.
- See if subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- See if pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- See if sending 2-weeks' worth of patches is helpful to the quitting process.
Detailed description
Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo control. Recently a number of studies have examined the use of patches prior to quitting. A meta-analysis indicates that such pre-cessation treatment with nicotine patches doubles the odds of quitting, compared to starting patch treatment on the quit day, as is traditionally done.
The proposed study would look at both pre-cessation treatment with nicotine patches as well as looking to see if sending clients nicotine patches is helpful in their quitting process. The rationale for pre-cessation treatment with patches is that using patches in this manner would make it easier to quit smoking because it may: reduce the reinforcing effects of cigarette smoking, thus helping to overcome conditioned behavior; reduce the need for inhaled nicotine as smokers naturally decrease their cigarette consumption to titrate the level of nicotine in their system; and/or increase compliance with patch use in the quitting phase.
The rationale for sending nicotine patches is that when callers must go and get the patches on their own it creates a barrier to their quitting so that sending nicotine patches directly to a callers' home would make it easier for them to stay on task and quit. This pilot will allow us to test the feasibility of sending pre-treatment nicotine patches and to examine the effects associated with the pre-cessation treatment phase.
This pilot project has the following specific aims, to examine whether:
- Subjects will use pre-cessation nicotine patches.
- Subjects in the pre-cessation nicotine patches go on to get more nicotine patches.
- Pre-cessation treatment with nicotine patches leads to a decrease in number of cigarettes smoked per day.
- Sending 2-weeks' worth of patches is helpful to the quitting process.
Results will add to the theoretical understanding of behavior change from which new, effective interventions can spring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-Patch and Telephone Counseling | Experimental | Behavioral: Telephone Counseling, Drug: Nicotine PatchesNicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date. Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. |
| Post-Patch and Telephone Counseling | Active comparator | Behavioral: Telephone Counseling, Drug: Nicotine PatchesNicotine patches (2 weeks' worth) are mailed directly to the subject. Clients are encouraged to start using their patches ON their quit date. Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. |
| Telephone Counseling and no patches sent | Active comparator | Behavioral: Telephone CounselingCounseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4 proactive follow-up calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >= 18 years old
- Daily smoker
- >=10 cigarettes per day
- Ready to quit within one month
- First time quitline caller
Key exclusion criteria (11 listed)
- Uses other form of tobacco
- Plan to use quitting aids other than nicotine patch
- Has any of the following conditions:
- Severe allergy to adhesive tape
- Arrhythmia
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 |
|---|---|---|
| Telephone CounselingTelephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date. | Behavioural | Post-Patch and Telephone Counseling, Pre-Patch and Telephone Counseling, Telephone Counseling and no patches sent |
| Nicotine PatchesAlso: HabitrolSubjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels). For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches. | Drug | Post-Patch and Telephone Counseling, Pre-Patch and Telephone Counseling |
Primary outcome
Number of Participants Who Have Not Used Tobacco in the Past 30 Days
Time frame: 2-months post enrollment
At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.
1 secondary outcome
Number of Participants With Serious Quit Attempts
Time frame: 2-months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Shu-Hong Zhu, Ph.D. principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telephone Counseling and Nicotine Patches in people with Smoking Cessation, run by University of California, San Diego 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 10 inclusion and 11 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 13 Feb 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Have Not Used Tobacco in the Past 30 Days (time frame: 2-months post 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 13 Feb 2020.