An interventional study of Transdermal Nicotine in Nicotine Dependence, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 116 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Drug: Transdermal Nicotine
* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used.
Drug: Transdermal Nicotine
Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
Also known as: Nicoderm CQ
Number of Participants With Biochemically Verified Smoking Abstinence
1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva
Time frame: Six months
| Milestone | Distress Tolerance Cessation Counseling | Standard Smoking Cessation Counseling |
|---|---|---|
| Started | 62 | 54 |
| Completed | 59 | 52 |
| Not completed | 3 | 2 |
1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva
| Participants | Distress Tolerance Cessation Counseling | Standard Smoking Cessation Counseling |
|---|---|---|
| Number of Participants With Biochemically Verified Smoking Abstinence | 11 | 12 |
Collected over 3 years, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Distress Tolerance Cessation Counseling | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Standard Smoking Cessation Counseling | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
Analysis population is not different from the assignment in Participant Flow.
| Age, Categorical(Participants) | New Smoking Cessation Counseling | Standard Smoking Cessation Counseling | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 62 | 54 | 116 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | New Smoking Cessation Counseling | Standard Smoking Cessation Counseling | Total |
|---|---|---|---|
| Mean | 44.97 ± 11.45 | 47.31 ± 10.98 | 46.06 ± 11.23 |
| Sex: Female, Male(Participants) | New Smoking Cessation Counseling | Standard Smoking Cessation Counseling | Total |
|---|---|---|---|
| Female | 26 | 22 | 48 |
| Male | 36 | 32 | 68 |
| Region of Enrollment(participants) | New Smoking Cessation Counseling | Standard Smoking Cessation Counseling | Total |
|---|---|---|---|
| United States | 62 | 54 | 116 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Butler Hospital