The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke. Secondary Objectives: * Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD) * Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes. * Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,550
Patch dosing will be consistent with the package insert
4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD.
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
Pathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt.
up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
Arizona State University
Phoenix, Arizona, United States
NOT_YET_RECRUITINGIndiana University
Indianapolis, Indiana, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center Research Institute, Inc
Kansas City, Kansas, United States
NOT_YET_RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
NOT_YET_RECRUITINGUW School of Medicine and Public Health
Milwaukee, Wisconsin, United States
RECRUITINGBiochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD
Time frame: 26 weeks post-TQD
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
salivary cotinine using a cut-off of less than 10 ng/ml to indicate abstinence from any nicotine product (combusted cigarettes, e-cigarettes, nicotine replacement therapy \[NRT\])
Time frame: 26 weeks post-TQD
Treatment Satisfaction
Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment.
Time frame: 8 weeks post-TQD
Cigarettes per day
Cigarettes per day based on the past 7 days.
Time frame: baseline, 8 and 26 weeks post-TQD
Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)
Scores range from 0 to 100 where higher scores indicate better quality of life.
Time frame: baseline, 8 and 26 weeks post-TQD
Money spent on cigarettes per week
Time frame: baseline, 8 and 26 weeks post-TQD
Smoking Cessation Self-efficacy using a single 10-point Likert scale
Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy.
Time frame: baseline, 8 and 26 weeks post-TQD
Psychological Distress measured by the 6-item Kessler screener (K6)
Total range of scores is from 0-24 where higher scores mean decreased psychological distress.
Time frame: baseline, 8 and 26 weeks post-TQD
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