A Phase 2 interventional study of nicotine transdermal system and bupropion in Tobacco Use Disorder, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-06.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 260 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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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:
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bupropion and MM counseling with placebo patch
Drug: bupropion · Behavioral: Medication Management · Drug: placebo patch
bupropion and Mayo counseling with placebo patch.
Drug: bupropion · Behavioral: Mayo Counseling · Drug: placebo patch
patch and MM counseling with placebo pills
Drug: nicotine transdermal system · Behavioral: Medication Management · Drug: placebo bupropion
patch and Mayo counseling with placebo pills
Drug: nicotine transdermal system · Behavioral: Mayo Counseling · Drug: placebo bupropion
starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks.
Also known as: Nicoderm
150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks
Also known as: Zyban
Brief manual based therapy; four 15 minute session over 10 weeks.
Manual based therapy; Weekly 30 minute sessions for 10 weeks
placebo patch containing no nicotine
placebo pills
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.
Time frame: 52 weeks
Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.
Time frame: 52 weeks
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.
| Milestone | 1 Bup+MM | 2 Bup+Mayo | 3 Patch+MM | 4 Patch+Mayo |
|---|---|---|---|---|
| Started | 70 | 63 | 62 | 65 |
| Completed | 59 | 52 | 49 | 53 |
| Not completed | 11 | 11 | 13 | 12 |
| Withdrew: Lost to follow-up | 11 | 11 | 13 | 12 |
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.
| Percentage of attended tx. sessions | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+mm | 4 Patch+Mayo |
|---|---|---|---|---|
| Percent Treatment Sessions Attended | 77.9 ± .05 | 85.9 ± .04 | 66.8 ± .06 | 66.6 ± .06 |
No measurements were reported for this outcome.
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1: Bup+MM | — | 1/70 (1.4%) | 1/70 (1.4%) |
| 2 Bup+Mayo | — | 0/63 (0%) | 3/63 (4.8%) |
| 3 Patch+mm | — | 1/62 (1.6%) | 0/62 (0%) |
| 4 Patch+Mayo | — | 0/65 (0%) | 2/65 (3.1%) |
| Event | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+mm | 4 Patch+Mayo |
|---|---|---|---|---|
| DeathGeneral disorders | 0/70 | 0/63 | 1/62 | 0/65 |
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/70 | 0/63 | 0/62 | 0/65 |
| Event | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+mm | 4 Patch+Mayo |
|---|---|---|---|---|
| Medication stopped due to reported side effects.General disorders | 1/70 | 3/63 | 0/62 | 2/65 |
| Age, Continuous(years) | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+MM | 4 Patch+Mayo | Total |
|---|---|---|---|---|---|
| Mean | 43.3 ± 12.5 | 42.4 ± 12.6 | 45.8 ± 12.6 | 43.1 ± 11.3 | 43.3 ± 12.2 |
| Sex: Female, Male(Participants) | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+MM | 4 Patch+Mayo | Total |
|---|---|---|---|---|---|
| Female | 44 | 31 | 35 | 38 | 148 |
| Male | 26 | 32 | 27 | 27 | 112 |
| Region of Enrollment(participants) | 1: Bup+MM | 2 Bup+Mayo | 3 Patch+MM | 4 Patch+Mayo | Total |
|---|---|---|---|---|---|
| United States | 70 | 63 | 62 | 65 | 260 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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