| ID | Type | Description | Link |
|---|---|---|---|
| P50DA019706 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | nicotine patch alone treatment |
|
| 2 | Experimental | nicotine lozenge alone treatment |
|
| 3 | Experimental | nicotine patch + lozenge combination treatment |
|
| 4 | Experimental | bupropion alone treatment |
|
| 5 | Experimental | bupropion + nicotine lozenge combination treatment |
|
| 6 | Placebo Comparator | placebo control (no active medication) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine patch | Drug | used according to FDA package label |
| |
| nicotine lozenge |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia). | 6 months post quit date |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy B. Baker, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW-CTRI Madison Research site | Madison | Wisconsin | 53711 | United States | ||
| UW-CTRI Milwaukee Research site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37335995 | Derived | Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2. | |
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |
| Label | URL |
|---|---|
| home page of agency performing the research | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Patch | nicotine patch alone treatment for nicotine dependence. |
| FG001 | Nicotine Lozenge | nicotine lozenge alone treatment |
| FG002 | Nicotine Patch + Lozenge | nicotine patch + lozenge combination treatment |
| FG003 | Bupropion | bupropion alone treatment |
| FG004 | Bupropion + Nicotine Lozenge | bupropion + nicotine lozenge combination treatment |
| FG005 | Placebo Control | placebo control (no active medication) treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Patch | nicotine patch alone treatment for nicotine dependence. |
| BG001 | Nicotine Lozenge | nicotine lozenge alone treatment |
| 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 |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed | Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia). | Posted | Number | participants with<10 ppm exhaled CO | 6 months post quit date |
|
6 months
collection of data at all visits and phone contacts
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Patch | nicotine patch alone treatment for nicotine dependence. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization: cardiovascular | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cold | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Piper, Megan E | University of Wisconsin | 608-265-5472 | mep@ctri.medicine.wisc.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| D016642 | Bupropion |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Drug |
used according to FDA-approved package directions |
|
| nicotine patch + nicotine lozenge | Drug | dosage of both according to FDA-approved dosing schedule |
|
| bupropion | Drug | dosage according to FDA-approved instructions |
|
| bupropion + lozenge | Drug | dosage according to FDA approved standard instructions |
|
| placebo | Drug | dosage same as active drug conditions |
|
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| 29251951 | Derived | Burgess-Hull AJ, Roberts LJ, Piper ME, Baker TB. The social networks of smokers attempting to quit: An empirically derived and validated classification. Psychol Addict Behav. 2018 Feb;32(1):64-75. doi: 10.1037/adb0000336. Epub 2017 Dec 18. |
| 25867447 | Derived | McCarthy DE, Ebssa L, Witkiewitz K, Shiffman S. Paths to tobacco abstinence: A repeated-measures latent class analysis. J Consult Clin Psychol. 2015 Aug;83(4):696-708. doi: 10.1037/ccp0000017. Epub 2015 Apr 13. |
| 24938369 | Derived | Smith SS, Fiore MC, Baker TB. Smoking cessation in smokers who smoke menthol and non-menthol cigarettes. Addiction. 2014 Dec;109(12):2107-17. doi: 10.1111/add.12661. Epub 2014 Jul 21. |
| 24893290 | Derived | Stein JH, Asthana A, Smith SS, Piper ME, Loh WY, Fiore MC, Baker TB. Smoking cessation and the risk of diabetes mellitus and impaired fasting glucose: three-year outcomes after a quit attempt. PLoS One. 2014 Jun 3;9(6):e98278. doi: 10.1371/journal.pone.0098278. eCollection 2014. |
| 22496918 | Derived | Johnson HM, Piper ME, Baker TB, Fiore MC, Stein JH. Effects of smoking and cessation on subclinical arterial disease: a substudy of a randomized controlled trial. PLoS One. 2012;7(4):e35332. doi: 10.1371/journal.pone.0035332. Epub 2012 Apr 9. |
| 22172440 | Derived | Asthana A, Piper ME, McBride PE, Ward A, Fiore MC, Baker TB, Stein JH. Long-term effects of smoking and smoking cessation on exercise stress testing: three-year outcomes from a randomized clinical trial. Am Heart J. 2012 Jan;163(1):81-87.e1. doi: 10.1016/j.ahj.2011.06.023. Epub 2011 Nov 14. |
| 21885891 | Derived | Julius BR, Ward BA, Stein JH, McBride PE, Fiore MC, Colbert LH. Ambulatory activity associations with cardiovascular and metabolic risk factors in smokers. J Phys Act Health. 2011 Sep;8(7):994-1003. doi: 10.1123/jpah.8.7.994. |
| 20236788 | Derived | Johnson HM, Gossett LK, Piper ME, Aeschlimann SE, Korcarz CE, Baker TB, Fiore MC, Stein JH. Effects of smoking and smoking cessation on endothelial function: 1-year outcomes from a randomized clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1988-95. doi: 10.1016/j.jacc.2010.03.002. Epub 2010 Mar 17. |
| BG002 | Nicotine Patch + Lozenge | nicotine patch + lozenge combination treatment |
| BG003 | Bupropion | bupropion alone treatment |
| BG004 | Bupropion + Nicotine Lozenge | bupropion + nicotine lozenge combination treatment |
| BG005 | Placebo Control | placebo control (no active medication) treatment |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
nicotine lozenge alone treatment |
| OG002 | Nicotine Patch + Lozenge | nicotine patch + lozenge combination treatment |
| OG003 | Bupropion | bupropion alone treatment |
| OG004 | Bupropion + Nicotine Lozenge | bupropion + nicotine lozenge combination treatment |
| OG005 | Placebo Control | placebo control (no active medication) treatment |
|
|
| 5 |
| 262 |
| 207 |
| 262 |
| EG001 | Nicotine Lozenge | nicotine lozenge alone treatment | 5 | 260 | 214 | 260 |
| EG002 | Nicotine Patch + Lozenge | nicotine patch + lozenge combination treatment | 5 | 267 | 227 | 267 |
| EG003 | Bupropion | bupropion alone treatment | 8 | 264 | 195 | 264 |
| EG004 | Bupropion + Nicotine Lozenge | bupropion + nicotine lozenge combination treatment | 6 | 262 | 217 | 262 |
| EG005 | Placebo Control | placebo control (no active medication) treatment | 6 | 189 | 129 | 189 |
| hospitalization: surgical | Surgical and medical procedures | Systematic Assessment |
|
| hospitalization: respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hopitalization: abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hospitalization: psychiatric and alcohol | Psychiatric disorders | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pregnancy |
|
| hospitalization: general | General disorders | Systematic Assessment |
|
| Skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Death: COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cough | Infections and infestations | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| flu | Infections and infestations | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| hiccups | General disorders | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Infections and infestations | Systematic Assessment |
|
| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| sleep disturbance | General disorders | Systematic Assessment |
|
| throat irritation | General disorders | Systematic Assessment |
|
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