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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA015365 | 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 purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Bup+MM | Experimental | bupropion and MM counseling with placebo patch |
|
| 2 Bup+Mayo | Experimental | bupropion and Mayo counseling with placebo patch. |
|
| 3 Patch+MM | Placebo Comparator | patch and MM counseling with placebo pills |
|
| 4 Patch+Mayo | Experimental | patch and Mayo counseling with placebo pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotine transdermal system | Drug | starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Treatment Sessions Attended | Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type. | 52 weeks |
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Light smokers (6-15 cigarettes per day
Inclusion Criteria:
Mentally and physically stable, non-pregnant, light smokers (6-15 cigarettes per day)
Exclusion Criteria:
Please contact site for more information
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| Name | Affiliation | Role |
|---|---|---|
| Peter W Gariti, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 6178 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17931823 | Background | Gariti P, Levin S, Whittingham T, Barou D, Kampman KM, Lynch K, Halbert CH, Alterman A. Why do those who request smoking treatment fail to attend the first appointment? J Subst Abuse Treat. 2008 Jul;35(1):62-7. doi: 10.1016/j.jsat.2007.08.009. Epub 2007 Oct 10. | |
| 19339135 | Result | Gariti P, Lynch K, Alterman A, Kampman K, Xie H, Varillo K. Comparing smoking treatment programs for lighter smokers with and without a history of heavier smoking. J Subst Abuse Treat. 2009 Oct;37(3):247-55. doi: 10.1016/j.jsat.2009.01.006. Epub 2009 Mar 31. |
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An in-person confirmatory screening interview consisted of a medical examination, structured psychological interview (Mini International Neuropsychiatric Interview; Sheenan et al., 1997), and biochemical testing (i.e., carbon monoxide reading of expired air [CO], blood alcohol concentration,and urine drug test).
The sample consists of 260 self-referred lighter smokers to an urban university setting. The first participant was enrolled in February 2005, and the last follow-up was completed in March 2008. A total of 302 met confirmatory screening criteria, and 260 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Bup+MM | bupropion and MM with placebo patch |
| FG001 | 2 Bup+Mayo | bupropion and Mayo counseling with placebo patch. |
| FG002 | 3 Patch+MM | patch and MM with placebo pills |
| FG003 | 4 Patch+Mayo | patch and Mayo counseling with placebo patch |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Bup+MM | bupropion and MM with placebo patch |
| BG001 | 2 Bup+Mayo | bupropion and Mayo counseling with placebo patch. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Treatment Sessions Attended | Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model. A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers. Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing. | Posted | Mean | Standard Error | Percentage of attended tx. sessions | 52 weeks |
|
The reported time frame for study related serious adverse events was 1 year. Two participants died prior to the week 52 follow-up of non-study related problems. The reported time frame for adverse events is the first 12 weeks (3 weeks post medication).
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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 | 1: Bup+MM | bupropion and MM with placebo patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication stopped due to reported side effects. | General disorders |
Missing data from some early terminations from treatment (i.e., 2 or less visits) may reflect dissatisfaction with counseling assignment or medication effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Gariti, Ph.D. | University of Pennsylvania | 215-222-3200 | 0 | gar1iti@mail.med.upenn.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 |
|---|---|
| D009538 | Nicotine |
| D016642 | Bupropion |
| D054539 | Medication Therapy Management |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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|
| bupropion | Drug | 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks |
|
|
| Medication Management | Behavioral | Brief manual based therapy; four 15 minute session over 10 weeks. |
|
| Mayo Counseling | Behavioral | Manual based therapy; Weekly 30 minute sessions for 10 weeks |
|
| placebo patch | Drug | placebo patch containing no nicotine |
|
| placebo bupropion | Drug | placebo pills |
|
| 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. |
| BG002 | 3 Patch+MM | patch and MM with placebo pills |
| BG003 | 4 Patch+Mayo | patch and Mayo counseling with placebo patch |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 1: Bup+MM |
bupropion and MM with placebo patch |
| OG001 | 2 Bup+Mayo | bupropion and Mayo counseling with placebo patch. |
| OG002 | 3 Patch+mm | patch and MM with placebo pills |
| OG003 | 4 Patch+Mayo | patch and Mayo counseling with placebo patch |
|
|
|
| Secondary | Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type. | PI is no longer with institution. All efforts have been exhausted to locate this data, but no data is available to be reported | Posted | 52 weeks |
|
|
| 1 |
| 70 |
| 1 |
| 70 |
| EG001 | 2 Bup+Mayo | bupropion and Mayo counseling with placebo patch. | 0 | 63 | 3 | 63 |
| EG002 | 3 Patch+mm | patch and MM with placebo pills | 1 | 62 | 0 | 62 |
| EG003 | 4 Patch+Mayo | patch and Mayo counseling with placebo patch | 0 | 65 | 2 | 65 |
| Death | General disorders |
|
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |