Smoking Cessation
Conditions
Keywords
Nicotine Replacement Therapy, Nicotine Patch, Smoking cessation, Telephone, Tobacco cessation, Counseling, Nicotine, Self-Help, Smoking abstinence, Tobacco Use Disorder
Brief 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. 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). 2. Test if sending placebo patches directly will also lead to a higher quit rate. 3. 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.
Interventions
DRUGNicotine Patch
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.
BEHAVIORALTelephone Counseling
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.
DRUGPlacebo
Placebo nicotine patch
OTHERSelf-Help Materials
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.
Sponsors
California Department of Health Services
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years old * Daily smoker * \>=6 cigarettes per day * Ready to quit within one month * First time quitline caller * Valid phone number * Valid address (no P.O. boxes) * California resident * Agree to participate in study and evaluation * English or Spanish speaking
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Six-month Continuous Abstinence From Cigarettes | 7 months post enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Quit for 30-days at 2-months Post Enrollment | 2-months post enrollment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Subjects are not mailed nicotine 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. | 1,200 |
| Patch (Placebo) Subjects are 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. | 1,201 |
| Patch (Real) Subjects are 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. | 1,799 |
| Total | 4,200 |
Baseline characteristics
| Characteristic | Usual Care | Patch (Placebo) | Patch (Real) | Total |
|---|---|---|---|---|
| Age, Customized 18-24 | 136 Participants | 145 Participants | 205 Participants | 486 Participants |
| Age, Customized 25-44 | 569 Participants | 534 Participants | 877 Participants | 1980 Participants |
| Age, Customized 45-64 | 453 Participants | 461 Participants | 648 Participants | 1562 Participants |
| Age, Customized 65+ | 40 Participants | 61 Participants | 68 Participants | 169 Participants |
| Age, Customized Unknown | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Education <12 | 314 Participants | 288 Participants | 444 Participants | 1046 Participants |
| Education BA/BS or Higher | 84 Participants | 92 Participants | 128 Participants | 304 Participants |
| Education HS Diploma | 405 Participants | 378 Participants | 595 Participants | 1378 Participants |
| Education Some College | 396 Participants | 442 Participants | 631 Participants | 1469 Participants |
| Education Unknown | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Language English | 1068 Participants | 1049 Participants | 1559 Participants | 3676 Participants |
| Language Spanish | 132 Participants | 152 Participants | 240 Participants | 524 Participants |
| Race/Ethnicity, Customized American Indian | 18 Participants | 16 Participants | 24 Participants | 58 Participants |
| Race/Ethnicity, Customized Asian | 24 Participants | 36 Participants | 46 Participants | 106 Participants |
| Race/Ethnicity, Customized Black | 191 Participants | 194 Participants | 307 Participants | 692 Participants |
| Race/Ethnicity, Customized Hispanic | 250 Participants | 270 Participants | 421 Participants | 941 Participants |
| Race/Ethnicity, Customized Multi-Race | 76 Participants | 73 Participants | 103 Participants | 252 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants | 3 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 638 Participants | 609 Participants | 888 Participants | 2135 Participants |
| Sex: Female, Male Female | 658 Participants | 645 Participants | 998 Participants | 2301 Participants |
| Sex: Female, Male Male | 542 Participants | 556 Participants | 801 Participants | 1899 Participants |
| Smoke Level 11+ | 848 Participants | 848 Participants | 1272 Participants | 2968 Participants |
| Smoke Level 6-10 | 352 Participants | 353 Participants | 527 Participants | 1232 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,200 | 0 / 1,201 | 0 / 1,799 |
| serious Total, serious adverse events | 0 / 1,200 | 0 / 1,201 | 0 / 1,799 |
Outcome results
Primary
Number of Participants With Six-month Continuous Abstinence From Cigarettes
Time frame: 7 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Six-month Continuous Abstinence From Cigarettes | 70 Participants |
| Patch (Placebo) | Number of Participants With Six-month Continuous Abstinence From Cigarettes | 101 Participants |
| Patch (Real) | Number of Participants With Six-month Continuous Abstinence From Cigarettes | 190 Participants |
Secondary
Number of Participants Quit for 30-days at 2-months Post Enrollment
Time frame: 2-months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Quit for 30-days at 2-months Post Enrollment | 136 Participants |
| Patch (Placebo) | Number of Participants Quit for 30-days at 2-months Post Enrollment | 173 Participants |
| Patch (Real) | Number of Participants Quit for 30-days at 2-months Post Enrollment | 334 Participants |