A Phase 4 interventional study of Nicotine patch and Quitline Counseling Phone Calls in Smoking Cessation, sponsored by University of Wisconsin, Madison. Recruiting at 5 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
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:
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 1,550 is above the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls.
Drug: Nicotine patch · Other: Quitline Counseling Phone Calls
The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content.
Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8)
Drug: Nicotine patch · Other: Counseling Sessions · Other: Pathways to Freedom · Other: Monetary Incentive
Patch dosing will be consistent with the package insert
Also known as: NicoDerm CQ
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)
Biochemically 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
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2030, 42 months after the start.
Of 53 non-industry phase 4 interventional studies under Smoking Cessation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 42 months is above that.
Counting every sponsor, half of 56 studies reached it within 35 months; a quarter within 21 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Wisconsin, Madison →