Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine (HDP)
This study has been completed.
Sponsor:
University of Pennsylvania
Information provided by (Responsible Party):
Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00956943
First received: July 23, 2009
Last updated: August 12, 2014
Last verified: August 2014
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Results First Received: January 14, 2013
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Factorial Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition: |
Nicotine Dependence |
| Interventions: |
Drug: Nicoderm CQ transdermal nicotine Drug: placebo |
Participant Flow
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Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Media ads asked treatment-seeking smokers to call for information about a smoking cessation program and to have their initial eligibility reviewed. Participants interested in the clinical trial and initially eligible attended an in-person session to determine their final eligibility. Recruitment was from 2009-2011. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| To be eligible, participants had to be: between age 18 and 55, smoke >10 cigarettes/day, and able to communicate in English. In addition, participants had to have a 3-HC/cotinine ratio that placed them in the top 3 quartiles of the 3-HC/cotinine ratio distribution to be consider fast nicotine metabolizers, which was >.18. |
Reporting Groups
| Description | |
|---|---|
| 21mg Transdermal Nicotine + Placebo Patch |
21mg transdermal nicotine + placebo patch Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks placebo : placebo patch |
| 42mg Transdermal Nicotine |
42mg transdermal nicotine Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks |
Participant Flow: Overall Study
| 21mg Transdermal Nicotine + Placebo Patch | 42mg Transdermal Nicotine | |
|---|---|---|
| STARTED | 43 | 44 |
| Baseline | 43 | 44 |
| COMPLETED | 34 | 34 |
| NOT COMPLETED | 9 | 10 |
| Lost to Follow-up | 9 | 10 |
Baseline Characteristics
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 21mg Transdermal Nicotine + Placebo Patch | No text entered. |
| 42mg Transdermal Nicotine | No text entered. |
| Total | Total of all reporting groups |
Baseline Measures
| 21mg Transdermal Nicotine + Placebo Patch | 42mg Transdermal Nicotine | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
43 | 44 | 87 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 43 | 44 | 87 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean (Standard Deviation) |
37.1 (9.0) | 38.8 (9.0) | 38 (9) |
|
Gender
[units: participants] |
|||
| Female | 22 | 23 | 45 |
| Male | 21 | 21 | 42 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 43 | 44 | 87 |
Outcome Measures
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Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| This was a proof of concept trial and, as such, was inadequately powered to detect statistically significant treatment arm effects and did not include a long-term follow-up assessment. |
More Information
Certain Agreements:
Results Point of Contact:
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Results Point of Contact:
Name/Title: Robert A. Schnoll, Ph.D.
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu
Organization: University of Pennsylvania
phone: 215-746-7143
e-mail: schnoll@mail.med.upenn.edu
| Responsible Party: | Robert Schnoll, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00956943 History of Changes |
| Other Study ID Numbers: |
809716 R21DA026889 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | July 23, 2009 |
| Results First Received: | January 14, 2013 |
| Last Updated: | August 12, 2014 |
| Health Authority: | United States: Food and Drug Administration |