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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA084718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.
Please see brief summary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Patch Treatment | Experimental | Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions. |
|
| Standard Patch Treatment | Active Comparator | Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Patch Treatment | Drug | 8-weeks of nicotine patch + 16-weeks of placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically Verified 7-day Point Prevalence Abstinence | To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy. | End of Treatment (week 24) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caryn Lerman, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tobacco Use Research Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18328642 | Result | Patterson F, Kerrin K, Wileyto EP, Lerman C. Increase in anger symptoms after smoking cessation predicts relapse. Drug Alcohol Depend. 2008 May 1;95(1-2):173-6. doi: 10.1016/j.drugalcdep.2008.01.013. Epub 2008 Mar 6. | |
| 20124230 | Result | Schnoll RA, Patterson F, Wileyto EP, Heitjan DF, Shields AE, Asch DA, Lerman C. Effectiveness of extended-duration transdermal nicotine therapy: a randomized trial. Ann Intern Med. 2010 Feb 2;152(3):144-51. doi: 10.7326/0003-4819-152-3-201002020-00005. |
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Once participants were enrolled and were eligible at the medical screening visit they were randomized to receiving either 8 weeks of 21 mg nicotine patch or 6 months of 21 mg nicotine patch treatment
Participants were recruited using mass media advertising from the the Greater Philadelphia area from June 2004 to April 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Patch Treatment | Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions. |
| FG001 | Standard Patch Treatment | Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Patch Treatment | Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions. |
| BG001 | Standard Patch 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 | Biochemically Verified 7-day Point Prevalence Abstinence | To evaluate the efficacy of standard (8-week) vs. extended (24-week) transdermal nicotine therapy. | Intention to Treat analysis (ITT) | Posted | Number | Participants | End of Treatment (week 24) |
|
4 years
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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 | Extended Patch Treatment | Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Systematic Assessment | 10/4/2007: Participant disclosed that she had recently had a stroke shortly after her last visit to the center. She sought medical attention immediately and was advised by her physician to discontinue use of the nicotine patch. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agressive Thoughts | Psychiatric disorders | Systematic Assessment | 10/23/2007-During Session 2 of the study participant reported feeling distraught & aggressive thoughts towards family members due to certain personal circumstances. Case discussed & participant provided with mental health helpline & other resources. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caryn Lerman | University of Pennsylvania | 215-746-7141 | clerman@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| 24-weeks of nicotine patch |
| Drug |
24-weeks of 21mg nicotine patch |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 19000709 | Result | Schnoll RA, Patterson F, Wileyto EP, Tyndale RF, Benowitz N, Lerman C. Nicotine metabolic rate predicts successful smoking cessation with transdermal nicotine: a validation study. Pharmacol Biochem Behav. 2009 Mar;92(1):6-11. doi: 10.1016/j.pbb.2008.10.016. Epub 2008 Oct 31. |
| 20336063 | Result | Lerman C, Jepson C, Wileyto EP, Patterson F, Schnoll R, Mroziewicz M, Benowitz N, Tyndale RF. Genetic variation in nicotine metabolism predicts the efficacy of extended-duration transdermal nicotine therapy. Clin Pharmacol Ther. 2010 May;87(5):553-7. doi: 10.1038/clpt.2010.3. Epub 2010 Mar 24. |
| 20147892 | Result | Ray R, Mitra N, Baldwin D, Guo M, Patterson F, Heitjan DF, Jepson C, Wileyto EP, Wei J, Payne T, Ma JZ, Li MD, Lerman C. Convergent evidence that choline acetyltransferase gene variation is associated with prospective smoking cessation and nicotine dependence. Neuropsychopharmacology. 2010 May;35(6):1374-82. doi: 10.1038/npp.2010.7. Epub 2010 Feb 10. |
| 23669629 | Derived | Ashare RL, Wileyto EP, Perkins KA, Schnoll RA. The first 7 days of a quit attempt predicts relapse: validation of a measure for screening medications for nicotine dependence. J Addict Med. 2013 Jul-Aug;7(4):249-54. doi: 10.1097/ADM.0b013e31829363e1. |
Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 282 |
| 4 |
| 282 |
| EG001 | Standard Patch Treatment | Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch. | 1 | 286 | 0 | 286 |
|
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| Seizure during Blood Draw | Nervous system disorders | Systematic Assessment | 4/17/2006: Participant had a 30-40 sec seizure after their blood draw. Participant recovered on their own from the seizure. Participant was monitored & their vitals were normal. Participants successfully completed rest of the session feeling normal |
|
| Hypertension | Cardiac disorders | Systematic Assessment | 2 Participants had high BP readings >200/110 during participating in the study. Both participants were encouraged to received medical help for uncontrolled hypertension, and discontinue nicotine patch treatment and only receive counseling. |
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