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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 4/6/26 | Other Identifier | UW Madison | |
| SMPH / CTRI | Other Identifier | UW Madison | |
| BPS-2024C1-36762 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Intervention | Active Comparator | The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls. |
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| Intensive Intervention | Experimental | 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. |
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| Intensive Incentivized Intervention | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | Patch dosing will be consistent with the package insert |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 26 weeks post-TQD |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | 26 weeks post-TQD |
| Treatment Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Piper, PhD | Contact | 608-265-5472 | mep@ctri.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan Piper, PhD | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Not yet recruiting | Phoenix | Arizona | 85004 | United States | |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Quitline Counseling Phone Calls | Other | 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. |
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| Counseling Sessions | Other | Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions |
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| Pathways to Freedom | Other | 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. |
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| Monetary Incentive | Other | up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) |
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Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment. |
| 8 weeks post-TQD |
| Cigarettes per day | Cigarettes per day based on the past 7 days. | 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. | baseline, 8 and 26 weeks post-TQD |
| Money spent on cigarettes per week | 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. | 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. | baseline, 8 and 26 weeks post-TQD |
| Indiana University |
| Not yet recruiting |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| University of Kansas Medical Center Research Institute, Inc | Not yet recruiting | Kansas City | Kansas | 66160 | United States |
| Virginia Commonwealth University | Not yet recruiting | Richmond | Virginia | 23298 | United States |
| UW School of Medicine and Public Health | Recruiting | Milwaukee | Wisconsin | 53233 | United States |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |