Smoking Cessation
Conditions
Keywords
smoking, cessation, tobacco
Brief summary
This study is a 2-arm randomized clinical trial (RCT). Participants motivated to quit smoking will be randomized to one of two treatments: 1) a Modern Usual Care (M-UC) vs. 2) Abstinence-Optimized Cessation Treatment (AOCT). The components for the optimized treatment have strong theoretical and empirical support from the investigators previous screening studies.
Detailed description
The ultimate goal of this research is to develop a chronic care treatment package for smokers that will address the challenges and opportunities of each phase of the cessation process - motivation, preparation, cessation, maintenance, and relapse recovery. That is, to develop treatments for smokers not yet ready to quit, those who are preparing to quit, those actively engaged in the quitting process and those who have tried to quit but relapsed. To achieve this goal, this research comprises three distinct research studies, each of which represent a phase in a comprehensive chronic care treatment model for clinical intervention with smokers in the primary care setting: the Motivation Study, the Cessation Study, and the Long-term Quitting Study. The goal of each study is to test and identify effective intervention components for distinct phases of the smoking cessation process. These components will then be combined for future research on the effectiveness of this chronic care treatment package
Interventions
DRUGPreparation Nicotine Mini-Lozenges
Nicotine lozenge prior to attempting to quit smoking
DRUGCombination NRT (nicotine patch + nicotine mini-lozenges)
26 weeks of combination NRT as part of a quit smoking attempt
BEHAVIORALIntensive In-Person Cessation Counseling
three 20-min In-person Cessation Counseling sessions
DRUGNicotine patch
8 weeks of nicotine patch
BEHAVIORALin-person counseling and quitline counseling
a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
BEHAVIORALExtended Maintenance Counseling Calls
8 Maintenance-phase smoking cessation counseling sessions
BEHAVIORALAutomated Adherence Calls
11 brief, automated calls reminding them to use their medications properly
Sponsors
Penn State University
University of Illinois at Chicago
University of Wisconsin, Madison
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
* age \>=18 years * smoking \>4 cigarettes/day for the previous 6 months * able to read, write, and speak English * have reliable phone access and agree to respond to Interactive Voice Response (IVR) phone prompts * and if currently using NRT, agreeing to use only study medication for the duration of the study * we will not exclude participants based on their prior use of cessation medication or if they use multiple tobacco products in order to enhance real-world generalization (these will be statistically controlled in analyses) * not currently attempting to quit smoking * not intending to quit smoking (defined as no plans to quit in the next month) * and planning to remain in the intervention catchment area for at least 12 months.
Exclusion criteria
* currently taking bupropion or varenicline * medical contraindications to using NRT including hospitalized (for at least one night) for a stroke, heart attack, congestive heart failure or diabetes in the last 30 days * diagnosis of or treatment for schizophrenia, a psychotic disorder or bipolar disorder in the last 10 years * and, if the participant is a woman of childbearing potential, being pregnant or intending to becoming pregnant or unwillingness to use an approved method of birth control during treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abstinence From Smoking | 6 months post treatment | The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million). |
Countries
United States
Participant flow
Recruitment details
Participants were patients from seven primary care clinics within two Wisconsin healthcare systems. Smokers who expressed interest in quitting smoking during a clinic visit were referred via the electronic health record (EHR) to the research study. Other smokers from these clinics were recruited via mailings and EHR messaging.
Pre-assignment details
Primary care patients who passed the phone screen were invited to attend a study visit at their referring clinic to learn more about the study, have eligibility confirmed, and provide written informed consent. No enrolled participants were excluded from the study prior to assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| Modern Usual Care Participants assigned to the M-UC will receive 8 weeks of nicotine patch, a single brief, in-person counseling session, a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), and will be signed up for either the QUITNOW app or the Web Coach (both provided by Alere Wellbeing, the vendor that provides the WTQL services).
Nicotine patch: 8 weeks of nicotine patch
in-person counseling and quitline counseling: a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website | 315 |
| Abstinence-Optimized Cessation Treatment There are 5 intervention components to include in the AOCT package: 1) Preparation Nicotine Mini-Lozenges; 2) 26-week postquit Combination NRT (nicotine patch + nicotine mini-lozenges); 3) Intensive In-Person Cessation Counseling; 4) Extended Maintenance Counseling Calls; and 5) Automated Adherence Calls.
Preparation Nicotine Mini-Lozenges: Nicotine lozenge prior to attempting to quit smoking
Combination NRT (nicotine patch + nicotine mini-lozenges): 26 weeks of combination NRT as part of a quit smoking attempt
Intensive In-Person Cessation Counseling: three 20-min In-person Cessation Counseling sessions
Extended Maintenance Counseling Calls: 8 Maintenance-phase smoking cessation counseling sessions
Automated Adherence Calls: 11 brief, automated calls reminding them to use their medications properly | 308 |
| Total | 623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 28 | 41 |
Baseline characteristics
| Characteristic | Modern Usual Care | Total | Abstinence-Optimized Cessation Treatment |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 12.9 | 49.7 years STANDARD_DEVIATION 12.7 | 50.0 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 92 Participants | 161 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 11 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) White | 211 Participants | 431 Participants | 220 Participants |
| Region of Enrollment United States | 315 participants | 623 participants | 308 participants |
| Sex: Female, Male Female | 184 Participants | 357 Participants | 173 Participants |
| Sex: Female, Male Male | 131 Participants | 266 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 315 | 0 / 308 |
| other Total, other adverse events | 66 / 315 | 139 / 308 |
| serious Total, serious adverse events | 0 / 315 | 0 / 308 |
Outcome results
Primary
Number of Participants With Abstinence From Smoking
The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide \< 6 parts per million).
Time frame: 6 months post treatment
Population: Adult smokers interested in quitting smoking who met inclusion and exclusion criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Modern Usual Care | Number of Participants With Abstinence From Smoking | 19 Participants |
| Abstinence-Optimized Cessation Treatment | Number of Participants With Abstinence From Smoking | 49 Participants |
p-value: <0.00195% CI: [1.69, 5.14]Regression, Logistic