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| ID | Type | Description | Link |
|---|---|---|---|
| 9P50CA143188 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Dean Health System | OTHER |
| Mercy Health System | NETWORK |
| Wake Forest University Health Sciences | OTHER |
| National Cancer Institute (NCI) |
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The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
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| 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
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| 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling before quit attempt | Behavioral | Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported 7-Day Point-Prevalence Abstinence | Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome. | 16 weeks post-quit |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Relapse | Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored. | During the first 6 months post-quit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan E Piper, PhD | University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Study Director |
| Timothy B Baker, PhD | University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| NIH |
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| 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
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| 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
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| 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
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| 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
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| 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
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| 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk | Experimental | How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
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| 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
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| 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16 | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
| 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
|
| 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16 | Experimental | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
|
|
| Minimal In-person counseling during quit attempt | Behavioral | Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.) |
|
| Intensive in-person counseling during the quit attempt | Behavioral | Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components. |
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| Minimal phone counseling during the quit attempt | Behavioral | Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome. |
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| Intensive phone counseling during the quit attempt | Behavioral | Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention. |
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| Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt | Drug | If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks. |
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| Short Term Nicotine Patch + Nicotine Gum during the quit attempt | Drug | If randomized to this condition: After the target quit day: Patch: IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks. IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks. Gum: IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks. |
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| Pre-Quit Nicotine Gum | Drug | If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch): Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day. |
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| Pre-Quit Nicotine Patch | Drug | If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum): Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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| Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum | Drug | If randomized to both the Prequit Patch and Prequit Gum Conditions: Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day. |
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| FG001 | 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG002 | 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG003 | 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG004 | 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG005 | 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG006 | 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG007 | 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG008 | 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG009 | 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG010 | 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG011 | 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG012 | 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG013 | 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG014 | 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG015 | 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG016 | 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG017 | 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG018 | 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt. |
| FG019 | 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk | How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG020 | 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG021 | 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG022 | 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG023 | 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG024 | 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG025 | 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG026 | 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG027 | 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG028 | 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16 | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| FG029 | 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG030 | 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| FG031 | 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16 | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG001 | 2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG002 | 3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG003 | 4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG004 | 5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG005 | 6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG006 | 7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG007 | 8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG008 | 9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG009 | 10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG010 | 11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG011 | 12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG012 | 13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG013 | 14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG014 | 15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG015 | 16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG016 | 17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG017 | 18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG018 | 19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt. |
| BG019 | 20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk | How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG020 | 21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG021 | 22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG022 | 23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG023 | 24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG024 | 25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG025 | 26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG026 | 27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG027 | 28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG028 | 29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16 | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG029 | 30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG030 | 31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt |
| BG031 | 32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16 | This arm of the project will address the following question: How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt |
| BG032 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Latency to Relapse | Latency to Relapse during the first 6 months post-quit, with relapse defined as 7 consecutive days of smoking; this outcome will be analyzed in a Cox regression survival analysis model with non-relapsers coded as right-censored. | Posted | Number | participants | During the first 6 months post-quit |
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| Primary | Self-Reported 7-Day Point-Prevalence Abstinence | Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers of the now-accepted manuscript (at the journal "Addiction") advised us to change the primary outcome to the current week 16 Self-Reported 7-Day Point-Prevalence Abstinence outcome. | Posted | Number | participants | 16 weeks post-quit |
|
AEs were reported for the duration of time when the participant was on medication, 1 week before the quit attempt (if given prequit meds) and 4 weeks after the quit attempt, for up to 16 weeks after the quit attempt.
Protocol prompted AE assessments occurred at week 1 (if given prequit meds) and weeks 1 and 4 postquit. Data from ad Hoc AE reports and protocol prompted AE assessments were combined. Only AEs where 5% or more of those from a study arm were reported and compared to other study arms.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch | Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch. Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day. | 1 | 173 | 32 | 173 | ||
| EG001 | Pre-Quit Nicotine Patch | Pre-Quit Nicotine Patch Participants randomized to this condition received Pre-Quit Nicotine Patch. Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day. | 1 | 156 | 27 | 156 | ||
| EG002 | Pre-Quit Nicotine Gum | Pre-Quit Nicotine Gum Participants randomized to this condition received Pre-Quit Nicotine Gum. Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day. | 0 | 166 | 22 | 166 | ||
| EG003 | No Pre-Quit Nicotine Patch Nor Gum | No Pre-Quit Nicotine Patch nor Gum Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum. | 0 | 142 | 0 | 142 | ||
| EG004 | Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum | Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt. | 5 | 333 | 51 | 304 | ||
| EG005 | Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt. | 2 | 304 | 55 | 333 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death- Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Cardiovascular | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vivid Dreams | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stevens Smith | UWisconsin | 608-262-7563 | sss@ctri.medicine.wisc.edu |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| # Participants Who Did Not Relapse (Not Smoking) |
|
The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day). |
| Regression, Cox |
| .664 |
| Cox Proportional Hazard |
| .980 |
| 2-Sided |
| 95 |
| .894 |
| 1.074 |
| No |
| Superiority or Other |
| The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day). | Regression, Cox | .814 | Cox Proportional Hazard | .989 | 2-Sided | 95 | .903 | 1.084 | No | Superiority or Other |
| The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day). | Regression, Cox | .093 | Cox Proportional Hazard | .925 | 2-Sided | 95 | .844 | 1.013 | No | Superiority or Other |
| The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day). | Regression, Cox | .716 | Cox Proportional Hazard | .983 | 2-Sided | 95 | .898 | 1.077 | No | Superiority or Other |
| The Cox regression model effects consisted of six treatment effects, 15 two-way treatment interactions, and three covariates : gender and two items from the Fagerstrom Test of Nicotine Dependence (Item 1: time to first cigarette; Item 4: cigarettes per day). | Regression, Cox | .511 | Cox Proportional Hazard | 1.031 | 2-Sided | 95 | .941 | 1.130 | No | Superiority or Other |
| OG001 | Pre-Quit Nicotine Patch | Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch). |
| OG002 | No Pre-Quit Nicotine Gum | Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum). |
| OG003 | Pre-Quit Nicotine Gum | Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum). |
| OG004 | No Counseling Before the Quit Attempt | Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt). |
| OG005 | Counseling Before the Quit Attempt | Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt). |
| OG006 | Minimal In-person Counseling During the Quit Attempt | Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt). |
| OG007 | Intensive In-person Counseling During the Quit Attempt | Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt). |
| OG008 | Minimal Phone Counseling During the Quit Attemp | Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt). |
| OG009 | Intensive Phone Counseling During the Quit Attempt | Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt). |
| OG010 | Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum | Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT). |
| OG011 | Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum | Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT). |
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