Smoking CessationPhase 3NCT01736085
Providing Free Nicotine Patches to Quitline Smokers
A Phase 3 study testing Telephone counseling, Voucher and Nicotine patches in people with Smoking Cessation, run by University of California, San Diego at 1 site in United States.
Trial summary
The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. 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, Voucher and Nicotine patches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,706 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- 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 or older
- Current smoker
- First time quitline caller
- Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
- English and/or Spanish speaking
- Valid phone number
Show all 9Show fewer
- Valid address
- CA resident
- Gave consent to participate in study and evaluation
Who cannot join
- Contraindication(s) to nicotine patches
- Uses a form of tobacco other than cigarettes
- Plans to use Chantix
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego; California Smokers' Helpline
San Diego, California, 92111
About this study
Official title: Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers
The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:
- To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
- To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
- To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
Read the detailed description
Tobacco smoking leads to nicotine dependence and serious health consequences. Telephone counseling has been shown to improve smokers' chances of quitting and is the most accessible of the three evidence-based forms of counseling (individual face-to-face, group, and telephone). It is well established that offering free NRT can attract many more smokers to call a quitline. However, how much the offer of free NRT helps quitline callers quit successfully is less well documented. There is currently no consistent guideline for quitline practice. We want to determine whether two weeks' worth of starter kit nicotine patches is efficacious for smokers who don't have access to free nicotine patches or quitting aids. The study also will provide data regarding the impact of a barrier to obtaining quitting aids by contrasting a direct mailing condition with a voucher condition. Further, the study will help us determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
The study uses a randomized controlled design. Smokers who call the Helpline during the recruitment phase, who meet eligibility requirements for the trial and give consent will be randomly assigned to one of six groups along two factors (nicotine patch and telephone counseling), as described below.
The 6 randomized groups are as follows: Group 1: Materials, Group 2: Voucher + Materials, Group 3: Patches + Materials, Group 4: Counseling, Group 5: Voucher + Counseling, Group 6: Patches + Counseling
Two months and seven months after their initial contact with the Helpline, all participants will receive two Assessment Interviews by phone. The interview will cover, as appropriate, smoking status, use of nicotine patches and other quitting aids, history of quitting, and satisfaction with services provided. The Assessment Interview lasts from 5-10 minutes.
- Conditions
- Smoking Cessation
- Being tested
- Telephone counseling, Voucher, Nicotine patches
- Keywords
- tobacco cessation, smoking cessation, nicotine, telephone counseling, self-help, smoking abstinence, tobacco use disorder, nicotine replacement therapy, voucher
- 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 is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling
VoucherBehavioural
Also called Voucher for nicotine patch
Subjects will receive a voucher for nicotine patches.
Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
Nicotine patchesDrug
Also called Nicotine patches sent directly
Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
| Study group | Role | What they receive |
|---|---|---|
| Material Group | No intervention | Subjects will receive self-help materials |
| Materials plus Voucher | Active comparator | Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches Receives: Behavioral: Voucher |
| Materials plus Patches | Active comparator | Subjects will receive self-help materials and a 2 week's worth of nicotine patches Receives: Drug: Nicotine patches |
| Counseling | Active comparator | Subjects will receive up to 5 sessions of telephone counseling Receives: Behavioral: Telephone counseling |
| Counseling plus Voucher | Active comparator | Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches. Receives: Behavioral: Telephone counseling; Behavioral: Voucher |
| Counseling plus Patches | Active comparator | Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches. Receives: Behavioral: Telephone counseling; Drug: Nicotine patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Six Months Prolonged Abstinence
At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.
Measured: Seven months post enrollment
Secondary outcomes (1)
Percentage of Smokers Making a 24-hour Quit Attempt
At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.
Measured: Two 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 posted29 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,706 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, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736085
- Sponsor's protocol ID
- P121218
- Status last verified
- Feb 2020
- First submitted
- 15 Nov 2012
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.
PubMed 12362011Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.
PubMed 18048638Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010 Apr 7;10:181. doi: 10.1186/1471-2458-10-181.
PubMed 20374628
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distribution of Voucher vs. Direct Mailing of Nicotine Patches to Quitline Smokers
- ClinicalTrials.gov ID
- NCT01736085
- Acronym / sponsor ID
- P121218
- Conditions
- Smoking Cessation
- Keywords
- tobacco cessation, smoking cessation, nicotine, telephone counseling, self-help, smoking abstinence, tobacco use disorder, nicotine replacement therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,706 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Posted 19 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 California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims:
- To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT)
- To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit
- To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
Detailed description
Tobacco smoking leads to nicotine dependence and serious health consequences. Telephone counseling has been shown to improve smokers' chances of quitting and is the most accessible of the three evidence-based forms of counseling (individual face-to-face, group, and telephone). It is well established that offering free NRT can attract many more smokers to call a quitline. However, how much the offer of free NRT helps quitline callers quit successfully is less well documented. There is currently no consistent guideline for quitline practice. We want to determine whether two weeks' worth of starter kit nicotine patches is efficacious for smokers who don't have access to free nicotine patches or quitting aids. The study also will provide data regarding the impact of a barrier to obtaining quitting aids by contrasting a direct mailing condition with a voucher condition. Further, the study will help us determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions
The study uses a randomized controlled design. Smokers who call the Helpline during the recruitment phase, who meet eligibility requirements for the trial and give consent will be randomly assigned to one of six groups along two factors (nicotine patch and telephone counseling), as described below.
The 6 randomized groups are as follows: Group 1: Materials, Group 2: Voucher + Materials, Group 3: Patches + Materials, Group 4: Counseling, Group 5: Voucher + Counseling, Group 6: Patches + Counseling
Two months and seven months after their initial contact with the Helpline, all participants will receive two Assessment Interviews by phone. The interview will cover, as appropriate, smoking status, use of nicotine patches and other quitting aids, history of quitting, and satisfaction with services provided. The Assessment Interview lasts from 5-10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Material Group | No intervention | –Subjects will receive self-help materials |
| Materials plus Voucher | Active comparator | Behavioral: VoucherSubjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches |
| Materials plus Patches | Active comparator | Drug: Nicotine patchesSubjects will receive self-help materials and a 2 week's worth of nicotine patches |
| Counseling | Active comparator | Behavioral: Telephone counselingSubjects will receive up to 5 sessions of telephone counseling |
| Counseling plus Voucher | Active comparator | Behavioral: Telephone counseling, Behavioral: VoucherSubjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches. |
| Counseling plus Patches | Active comparator | Behavioral: Telephone counseling, Drug: Nicotine patchesSubjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Current smoker
- First time quitline caller
- Not eligible for nicotine patches through other programs such as MediCal or Los Angeles County which provides free nicotine patches
- English and/or Spanish speaking
Key exclusion criteria (3 listed)
- Contraindication(s) to nicotine patches
- Uses a form of tobacco other than cigarettes
- Plans to use Chantix
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 is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling | Behavioural | Counseling, Counseling plus Patches, Counseling plus Voucher |
| VoucherAlso: Voucher for nicotine patchSubjects will receive a voucher for nicotine patches. Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date. | Behavioural | Counseling plus Voucher, Materials plus Voucher |
| Nicotine patchesAlso: Nicotine patches sent directlySubjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date. | Drug | Counseling plus Patches, Materials plus Patches |
Primary outcome
Number of Participants With Six Months Prolonged Abstinence
Time frame: Seven months post enrollment
At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.
1 secondary outcome
Percentage of Smokers Making a 24-hour Quit Attempt
Time frame: Two months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12362011Zhu SH, Anderson CM, Tedeschi GJ, Rosbrook B, Johnson CE, Byrd M, Gutierrez-Terrell E. Evidence of real-world effectiveness of a telephone quitline for smokers. N Engl J Med. 2002 Oct 3;347(14):1087-93. doi: 10.1056/NEJMsa020660.
- Background: PubMed 18048638Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i81-6. doi: 10.1136/tc.2007.020701.
- Background: PubMed 20374628Cummings KM, Fix BV, Celestino P, Hyland A, Mahoney M, Ossip DJ, Bauer U. Does the number of free nicotine patches given to smokers calling a quitline influence quit rates: results from a quasi-experimental study. BMC Public Health. 2010 Apr 7;10:181. doi: 10.1186/1471-2458-10-181.
- California Smokers' Helpline, University of California, San DiegoLink provided by the sponsor.
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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 Telephone counseling, Voucher 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 9 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 19 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 19 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 Months Prolonged Abstinence (time frame: Seven months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736085, which also lists 3 linked publications.
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 19 Feb 2020.