Smoking Cessation
Conditions
Keywords
tobacco cessation, smoking cessation, nicotine, telephone counseling, self-help, smoking abstinence, tobacco use disorder, nicotine replacement therapy, voucher
Brief 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. 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: 1. 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) 2. 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 3. 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.
Interventions
BEHAVIORALTelephone counseling
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
BEHAVIORALVoucher
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.
DRUGNicotine patches
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.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Valid address * CA resident * Gave consent to participate in study and evaluation
Exclusion criteria
* Contraindication(s) to nicotine patches * Uses a form of tobacco other than cigarettes * Plans to use Chantix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Six Months Prolonged Abstinence | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Smokers Making a 24-hour Quit Attempt | Two months post enrollment | At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Material Group Subjects will receive self-help materials | 529 |
| Materials Plus Voucher Subjects will receive self-help materials and a voucher for 2 week's worth of nicotine patches
Voucher: 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. | 530 |
| Materials Plus Patches Subjects will receive self-help materials and a 2 week's worth of nicotine patches
Nicotine patches: 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. | 793 |
| Counseling Subjects will receive up to 5 sessions of telephone counseling
Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by 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 | 530 |
| Counseling Plus Voucher Subjects will receive up to 5 sessions of telephone counseling plus a voucher for 2 week's worth of nicotine patches.
Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by 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
Voucher: Subjects will receive a voucher for nicotine patches.
Subjects ra | 530 |
| Counseling Plus Patches Subjects will receive up to 5 sessions of telephone counseling plus 2 week's worth of nicotine patches.
Telephone counseling: Telephone counseling is conducted in the appropriate language (English and Spanish) by 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
Nicotine patches: Subjects will receive nicotine patches directly sent to their home.
Subj | 794 |
| Total | 3,706 |
Baseline characteristics
| Characteristic | Total | Material Group | Materials Plus Voucher | Materials Plus Patches | Counseling | Counseling Plus Voucher | Counseling Plus Patches |
|---|---|---|---|---|---|---|---|
| Age, Customized 18-24 years | 392 Participants | 55 Participants | 70 Participants | 77 Participants | 62 Participants | 52 Participants | 76 Participants |
| Age, Customized 25-44 years | 1422 Participants | 203 Participants | 207 Participants | 304 Participants | 211 Participants | 200 Participants | 297 Participants |
| Age, Customized 45-64 years | 1651 Participants | 236 Participants | 217 Participants | 354 Participants | 231 Participants | 245 Participants | 368 Participants |
| Age, Customized 65+ years | 241 Participants | 35 Participants | 36 Participants | 58 Participants | 26 Participants | 33 Participants | 53 Participants |
| Cigs per day <15 | 1578 Participants | 223 Participants | 261 Participants | 348 Participants | 201 Participants | 215 Participants | 330 Participants |
| Cigs per day <=15 | 2128 Participants | 306 Participants | 269 Participants | 445 Participants | 329 Participants | 315 Participants | 464 Participants |
| Education <=12 | 660 Participants | 111 Participants | 99 Participants | 132 Participants | 96 Participants | 99 Participants | 123 Participants |
| Education BS/BA + | 375 Participants | 50 Participants | 41 Participants | 79 Participants | 53 Participants | 52 Participants | 100 Participants |
| Education GED/HSD | 1100 Participants | 150 Participants | 148 Participants | 259 Participants | 159 Participants | 152 Participants | 232 Participants |
| Education Some College | 1571 Participants | 218 Participants | 242 Participants | 323 Participants | 222 Participants | 227 Participants | 339 Participants |
| Race/Ethnicity, Customized American Indian and Alaska Native | 56 Participants | 6 Participants | 11 Participants | 12 Participants | 8 Participants | 9 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 113 Participants | 15 Participants | 22 Participants | 30 Participants | 21 Participants | 9 Participants | 16 Participants |
| Race/Ethnicity, Customized Black | 493 Participants | 70 Participants | 80 Participants | 117 Participants | 59 Participants | 57 Participants | 110 Participants |
| Race/Ethnicity, Customized Hispanic | 698 Participants | 109 Participants | 94 Participants | 140 Participants | 94 Participants | 122 Participants | 139 Participants |
| Race/Ethnicity, Customized Multi-Race | 269 Participants | 39 Participants | 55 Participants | 52 Participants | 41 Participants | 31 Participants | 51 Participants |
| Race/Ethnicity, Customized Other | 22 Participants | 2 Participants | 5 Participants | 4 Participants | 6 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 2055 Participants | 288 Participants | 263 Participants | 438 Participants | 301 Participants | 300 Participants | 465 Participants |
| Sex: Female, Male Female | 1867 Participants | 279 Participants | 283 Participants | 377 Participants | 244 Participants | 265 Participants | 419 Participants |
| Sex: Female, Male Male | 1839 Participants | 250 Participants | 247 Participants | 416 Participants | 286 Participants | 265 Participants | 375 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 529 | 0 / 530 | 0 / 793 | 0 / 530 | 0 / 530 | 0 / 794 |
| serious Total, serious adverse events | 0 / 529 | 0 / 530 | 0 / 793 | 0 / 530 | 0 / 530 | 0 / 794 |
Outcome results
Primary
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.
Time frame: Seven months post enrollment
Population: intent-to-treat; we are looking at the marginal means
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With Six Months Prolonged Abstinence | 61 Participants |
| Voucher | Number of Participants With Six Months Prolonged Abstinence | 76 Participants |
| Patches | Number of Participants With Six Months Prolonged Abstinence | 151 Participants |
Secondary
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.
Time frame: Two months post enrollment
Population: those evaluated at 2-months; we are looking at the marginal means
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Percentage of Smokers Making a 24-hour Quit Attempt | 455 Participants |
| Voucher | Percentage of Smokers Making a 24-hour Quit Attempt | 533 Participants |
| Patches | Percentage of Smokers Making a 24-hour Quit Attempt | 879 Participants |