Smoking Cessation, Tobacco Use Disorder
Conditions
Keywords
Internet-Assisted Tobacco Treatments, Online Smoking Cessation Programs, Nicotine Patches, Telephone Counseling, Smoking Abstinence
Brief summary
People who smoke cigarettes have an increased risk of developing emphysema, heart disease, and certain types of cancer. This study will evaluate the effectiveness of providing free nicotine patches from an online smoking cessation program, with and without telephone counseling, at improving quit rates in cigarette smokers.
Detailed description
The objective of this project is to determine the efficacy and cost-effectiveness of providing access to free nicotine patches, with or without a required linkage to proactive telephone counseling, as adjuncts to internet-assisted tobacco treatment. Online cessation services will be provided by the Center for Health Communication Research at the University of Michigan. This investigation has three specific aims and one exploratory aim: * Specific Aim 1: To determine the efficacy of providing access to free nicotine patches as an addition to online smoking cessation services. * Specific Aim 2: To determine the efficacy of providing access to free nicotine patches linked with proactive telephone counseling as an addition to online smoking cessation services. * Specific Aim 3: To determine the cost-effectiveness of providing access to free nicotine patches, with or without linkage to proactive phone counseling, as additions to online cessation services. * Exploratory Aim 1: To examine potential mediators and moderators of intervention effects. An examination of potential mediators will identify key psychological and behavioral processes (e.g. medication adherence, self-efficacy, etc.) that underlie how the interventions affect the process of quitting and offer guidance regarding key targets for future research. An examination of potential moderators (e.g. level of dependence, income, gender) will identify candidate subgroups for which the proposed interventions may be more effective and cost- effective. Smokers searching online for help quitting (N=2,475) will be recruited and randomized to receive one of three treatments: 1. online smoking cessation services (i.e. web), 2. online cessation services plus access to free nicotine patches (i.e.web+patch), 3. online cessation services with access to free patches contingent upon participation in proactive telephone counseling (i.e. web+patch+phone). The Center for Health Communications Research at the University of Michigan will serve as the smoking cessation website for this research project. Developed by Vic Strecher and colleagues, Project Quit is a web-based program designed to help individuals who would like to quit smoking in the next 30 days. The program is grounded in cognitive-behavioral methods of smoking cessation and relapse prevention. The web-based smoking cessation intervention features highly tailored email messages. Once enrolled in the project and the baseline assessment is completed, participants receive six tailored web sessions namely: * Action plan (1 week before quit date); * Barriers 1 (2 days before quit date); * Supportive message (on quit date); * Barriers 2 (2 days after quit date); * Motivation (1 week after quit date); * Testimonial (2 weeks after quit date). Evaluations will occur at baseline and at 1-, 3-, and 9-months post-enrollment. The primary outcome measure will be self-reported 6-month prolonged abstinence measured at the 9-month evaluation. This proposal addresses a critical need for evidence-based cessation treatments for smokers. At the completion of this project, it is our expectation that we will have identified an effective online intervention package (or packages) for dissemination of internet-assisted tobacco treatment. This study will enroll people recruited via online sources. Participants will complete a baseline survey about their smoking habits and quit history. Participants will then be randomly assigned to one of the following three treatment groups: * Group 1 participants will receive access to an online tailored stop smoking program. * Group 2 participants will receive free access to nicotine patches and an online tailored stop smoking program. * Group 3 participants will receive telephone counseling, free access to nicotine patches and an online tailored stop smoking program. Participants receiving telephone counseling will receive 5 phone calls over a 2-month period to discuss their personal smoking cessation plan; they must complete the pre-quit and 7-10 day calls in order to receive the nicotine patches. At 1, 3, and 9 months post-enrollment, all participants will complete online surveys about their smoking cessation experience. Participants will be contacted by phone to complete the surveys if they do not complete them online.
Interventions
DRUGNicotine patches
Participants will wear nicotine patches.
BEHAVIORALTelephone counseling
Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
BEHAVIORALiQuit Smoking website
Participants will access the Project Quit (iQuit Smoking) website.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Currently smokes 10 or more cigarettes per day * Does not use any tobacco products other than cigarettes * Willing to set a quit date within 2 to 4 weeks following study entry * Willing to use a nicotine patch * Able to speak English * Access to Internet, email, and telephone at work or home * Resident of the United States * Only one person per household is eligible to enroll
Exclusion criteria
* Medically unable to use the nicotine patch (e.g., pregnant, history of a heart attack) * Currently uses nicotine replacement therapy (NRT) products * Currently uses or plans to use Bupropion SR, Wellbutrin, or Zyban
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 6-month Prolonged Abstinence From Smoking | Measured at 9 Months post-randomization | Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis. |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported 30-day Prolonged Abstinence at 9-month Follow up | 9 months post randomization |
| Self-reported 30-day Prolonged Abstinence at 3-month Follow up | 3-months post randomization |
Countries
United States
Participant flow
Pre-assignment details
Interested individuals completed a screening survey to determine eligibility. Following study consent, participants completed two emailed surveys over the next two days and a phone confirmation call before being randomized. These check-ins confirmed the participant had valid contact information and maintained their desire to quit smoking.
Participants by arm
| Arm | Count |
|---|---|
| NRT Patch, Phone Counseling, Internet As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website. | 827 |
| Nicotine Patches and Internet As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.
Nicotine patches: Participants will wear nicotine patches.
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website. | 830 |
| Internet Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).
iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website. | 828 |
| Total | 2,485 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 170 | 138 | 201 |
| Overall Study | Removed by study staff | 2 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 2 | 38 |
Baseline characteristics
| Characteristic | NRT Patch, Phone Counseling, Internet | Total | Internet | Nicotine Patches and Internet |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 98 Participants | 28 Participants | 39 Participants |
| Age, Categorical Between 18 and 65 years | 796 Participants | 2387 Participants | 800 Participants | 791 Participants |
| Age, Continuous | 44.27 Years STANDARD_DEVIATION 12.03 | 44.26 Years STANDARD_DEVIATION 11.89 | 44.20 Years STANDARD_DEVIATION 11.64 | 44.31 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 96 Participants | 33 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 797 Participants | 2389 Participants | 795 Participants | 797 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Highest education level College graduate | 151 participants | 458 participants | 146 participants | 161 participants |
| Highest education level High school or less | 236 participants | 643 participants | 201 participants | 206 participants |
| Highest education level Some college | 440 participants | 1384 participants | 481 participants | 463 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 16 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 21 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 176 Participants | 64 Participants | 56 Participants |
| Race (NIH/OMB) More than one race | 32 Participants | 79 Participants | 24 Participants | 23 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 37 Participants | 13 Participants | 11 Participants |
| Race (NIH/OMB) White | 714 Participants | 2151 Participants | 712 Participants | 725 Participants |
| Region of Enrollment United States | 827 participants | 2485 participants | 828 participants | 830 participants |
| Sex: Female, Male Female | 562 Participants | 1721 Participants | 578 Participants | 581 Participants |
| Sex: Female, Male Male | 265 Participants | 764 Participants | 250 Participants | 249 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 / 827 | 0 / 830 | 0 / 828 |
| serious Total, serious adverse events | 3 / 827 | 0 / 830 | 2 / 828 |
Outcome results
Primary
Self-reported 6-month Prolonged Abstinence From Smoking
Participants complete the final study survey 9 months following enrollment in the program. They are asked to report when they had last smoked a cigarette, even a puff. Participants who report that they have not smoked in the past 6 months are counted as abstinent for the purposes of our study analysis.
Time frame: Measured at 9 Months post-randomization
Population: All currently enrolled participants were invited via email to complete an online follow-up survey. Participants who did not respond to the email received phone calls from study staff asking them to complete the survey online. Results to this outcome measure are from those subjects who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NRT Patch, Phone Counseling, Internet | Self-reported 6-month Prolonged Abstinence From Smoking | 252 participants |
| Nicotine Patches and Internet | Self-reported 6-month Prolonged Abstinence From Smoking | 194 participants |
| Internet | Self-reported 6-month Prolonged Abstinence From Smoking | 109 participants |
Secondary
Self-reported 30-day Prolonged Abstinence at 3-month Follow up
Time frame: 3-months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NRT Patch, Phone Counseling, Internet | Self-reported 30-day Prolonged Abstinence at 3-month Follow up | 379 participants |
| Nicotine Patches and Internet | Self-reported 30-day Prolonged Abstinence at 3-month Follow up | 299 participants |
| Internet | Self-reported 30-day Prolonged Abstinence at 3-month Follow up | 138 participants |
Secondary
Self-reported 30-day Prolonged Abstinence at 9-month Follow up
Time frame: 9 months post randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NRT Patch, Phone Counseling, Internet | Self-reported 30-day Prolonged Abstinence at 9-month Follow up | 310 participants |
| Nicotine Patches and Internet | Self-reported 30-day Prolonged Abstinence at 9-month Follow up | 268 participants |
| Internet | Self-reported 30-day Prolonged Abstinence at 9-month Follow up | 176 participants |