Smoking CessationPhase 3NCT00851357
Telephone Counseling and the Distribution of Nicotine Patches to Smokers
A Phase 3 study testing Nicotine Patch, Telephone Counseling and Self-Help Materials 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 determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to: 1. 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?
- Nicotine Patch, Telephone Counseling and Self-Help Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 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
- >=6 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 or Spanish speaking
Who cannot join
- Uses other form of tobacco
- Use of Zyban or Chantix
- One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Californian, San Diego: California Smokers' Helpline
San Diego, California, 92111
About this study
Official title: The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline
The primary purpose of this study is to determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:
- Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
- Test if sending placebo patches directly will also lead to a higher quit rate.
- Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
Read the detailed description
Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Patch, Telephone Counseling, Placebo, Self-Help Materials
- Keywords
- Nicotine Replacement Therapy, Nicotine Patch, Smoking cessation, Telephone, Tobacco cessation, Counseling, Nicotine, Self-Help, Smoking abstinence, Tobacco Use Disorder
- 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.
Nicotine PatchDrug
Also called Habitrol
Subjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches.
Telephone CounselingBehavioural
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling.
PlaceboDrug
Also called Non-nicotine patch
Placebo nicotine patch
Self-Help MaterialsOther
Subjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group.
Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day.
| Study group | Role | What they receive |
|---|---|---|
| Active patches and telephone counseling | Experimental | Proactive Telephone Counseling and 8-weeks of nicotine patches Receives: Drug: Nicotine Patch; Behavioral: Telephone Counseling |
| Placebo patches and telephone counseling | Placebo comparator | Proactive Telephone Counseling and 8-weeks of placebo patches Receives: Behavioral: Telephone Counseling; Drug: Placebo |
| Telephone counseling | Active comparator | Proactive Telephone Counseling Receives: Behavioral: Telephone Counseling |
| Active patches and materials | Active comparator | 8-weeks of nicotine patches and materials Receives: Drug: Nicotine Patch; Other: Self-Help Materials |
| Placebo patches and materials | Active comparator | 8-weeks placebo patches and materials Receives: Drug: Placebo; Other: Self-Help Materials |
| Materials | Active comparator | Self-help materials Receives: Other: Self-Help Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Measured: 7 months post enrollment
Secondary outcomes (1)
Number of Participants Quit for 30-days at 2-months Post Enrollment
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 posted25 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2010
- Study completionDec 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.
- More trials run by University of California, San DiegoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- California Department of Health Services
- Responsible party
- Principal investigator, Shu-Hong Zhu, University of California, San Diego
- Investigators
- Shu-Hong Zhu, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851357
- Sponsor's protocol ID
- CDPH 05-45834
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2009
- 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
- The Efficacy of Telephone Counseling and the Centralized Distribution of Nicotine Replacement Therapy Through a Smoking Cessation Quitline
- ClinicalTrials.gov ID
- NCT00851357
- Acronym / sponsor ID
- CDPH 05-45834
- Conditions
- Smoking Cessation
- Keywords
- Nicotine Replacement Therapy, Nicotine Patch, Smoking cessation, Telephone, Tobacco cessation, Counseling, Nicotine, Self-Help
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- California Department of Health Services
- Study start
- Feb 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 10 Feb 2020
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 determine the effects of distributing free nicotine replacement therapy (NRT) to tobacco quitline callers directly. Specifically, this study aims to:
- Test if sending active nicotine patches directly will lead to a higher quit rate, compared to a condition where the quitline assists the smokers to obtain patches by other means (e.g. via their health plans).
- Test if sending placebo patches directly will also lead to a higher quit rate.
- Test if quitline counseling increases the quit rate when the smokers already receive the nicotine patches.
Detailed description
Studies have shown that statewide tobacco quitlines can dramatically increase call volume by offering direct mailings of free nicotine replacement therapy (NRT) products. Sending free NRT such as patches to quitline callers, however, often requires a large budget because quitlines have a large number of smokers calling for help each year. A strong rationale is needed for state funding agencies to pay for the patches, which are generally considered the responsibility of health plans. This study will contrast the condition of sending nicotine patches directly from the quitline with a condition where the quitline assists smokers to obtain patches by other means, primarily through their health plans. The study aims to demonstrate that sending patches immediately after smokers call the quitline has a motivational effect that will lead to a higher quit rate than if smokers have to obtain the patches themselves, even if they are able to obtain them for free. To tease apart how much of the effect of sending patches directly from the quitline is due to the active ingredient in the patches and how much is due to motivational effects, this study adds a placebo condition. We hypothesize that the active patches condition will outperform the placebo condition, and the sending of placebo patches will outperform the condition in which the smokers obtain the nicotine patches themselves. We also hypothesize that counseling has its own effect on quitting above and beyond that of the nicotine patches. This study will supply data that can be used to decide what role nicotine replacement therapy should play in publicly funded tobacco cessation programs. Results will also add to the theoretical understanding of behavior change from which new, effective interventions can spring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Active patches and telephone counseling | Experimental | Drug: Nicotine Patch, Behavioral: Telephone CounselingProactive Telephone Counseling and 8-weeks of nicotine patches |
| Placebo patches and telephone counseling | Placebo comparator | Behavioral: Telephone Counseling, Drug: PlaceboProactive Telephone Counseling and 8-weeks of placebo patches |
| Telephone counseling | Active comparator | Behavioral: Telephone CounselingProactive Telephone Counseling |
| Active patches and materials | Active comparator | Drug: Nicotine Patch, Other: Self-Help Materials8-weeks of nicotine patches and materials |
| Placebo patches and materials | Active comparator | Drug: Placebo, Other: Self-Help Materials8-weeks placebo patches and materials |
| Materials | Active comparator | Other: Self-Help MaterialsSelf-help materials |
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
- >=6 cigarettes per day
- Ready to quit within one month
- First time quitline caller
Key exclusion criteria (3 listed)
- Uses other form of tobacco
- Use of Zyban or Chantix
- One of the following conditions: Severe allergy to adhesive tape, Arrhythmia, Angina, Heart attack within last year, Stroke within last year, Uncontrolled high blood pressure, Insulin-dependent diabetes, Pregnancy
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 |
|---|---|---|
| Nicotine PatchAlso: HabitrolSubjects are randomized into 1 of 3 conditions: active, placebo or usual care. Usual care subjects are not mailed patches; however, we facilitate their use by providing a certificate that can be used by the State Medicaid program and some insurance companies to obtain free patches. For those mailed patches directly, we will mail 8 weeks of patches. Dosage depends on the number of cigarettes per day (cpd). Light smokers (6-10 cpd) will receive 6 weeks of 14 mg and 2 weeks of 7 mg patches. Heavy smokers (11+ cpd) will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg patches. Placebo patches will have no nicotine, but will be packaged to mimic the active patches. | Drug | Active patches and materials, Active patches and telephone counseling |
| Telephone CounselingSubjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Telephone counseling includes a comprehensive pre-quit session (to include motivation, planning, and setting of a quit date and discussion of nicotine patch use) plus up to 5 proactive follow-up calls. Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. | Behavioural | Active patches and telephone counseling, Placebo patches and telephone counseling, Telephone counseling |
| PlaceboAlso: Non-nicotine patchPlacebo nicotine patch | Drug | Placebo patches and materials, Placebo patches and telephone counseling |
| Self-Help MaterialsSubjects call the Helpline and are screened for services. Eligible clients who give consent will be randomly assigned to a group. Subjects will be randomized into one of 2 behavioral conditions: telephone counseling or self-help materials. Reading materials and written consent will be mailed to all study subjects the next business day. | Other | Active patches and materials, Materials, Placebo patches and materials |
Primary outcome
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Time frame: 7 months post enrollment
1 secondary outcome
Number of Participants Quit for 30-days at 2-months Post Enrollment
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
University of California, San Diego
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 Nicotine Patch, Telephone Counseling and Self-Help Materials 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 3 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. Some participants in this study may receive a placebo. 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 10 Feb 2020). 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 With Six-month Continuous Abstinence From Cigarettes (time frame: 7 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; AzTrials last refreshed its copy on 8 Nov 2026.