Smoking Cessation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGNicotine patch
Patch dosing will be consistent with the package insert
OTHERQuitline Counseling Phone Calls
4, 15 to 20-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.
OTHERCounseling Sessions
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions
OTHERPathways to Freedom
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.
OTHERMonetary Incentive
up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
Sponsors
University of Wisconsin, Madison
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* self-identify as Black * smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to15 days/month) * motivated to quit smoking * willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Exclusion criteria
* currently taking bupropion for non-smoking cessation reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day | 26 weeks post-TQD | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day | 26 weeks post-TQD | 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 \[NRT\]) |
| Treatment Satisfaction | 8 weeks post-TQD | Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment. |
| Cigarettes per day | baseline, 8 and 26 weeks post-TQD | Cigarettes per day based on the past 7 days. |
| Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12) | baseline, 8 and 26 weeks post-TQD | Scores range from 0 to 100 where higher scores indicate better quality of life. |
| Money spent on cigarettes per week | baseline, 8 and 26 weeks post-TQD | — |
| Smoking Cessation Self-efficacy using a single 10-point Likert scale | baseline, 8 and 26 weeks post-TQD | Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy. |
| Psychological Distress measured by the 6-item Kessler screener (K6) | baseline, 8 and 26 weeks post-TQD | Total range of scores is from 0-24 where higher scores mean decreased psychological distress. |
Countries
United States
Contacts
CONTACTMegan Piper, PhD
PRINCIPAL_INVESTIGATORMegan Piper, PhD
UW School of Medicine and Public Health
Outcome results
None listed