Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine (HDP)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, 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

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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
Overall Participants Analyzed; [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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1. Primary:

Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment [ Time Frame: After 8 weeks of treatment with the patch, outcome will be measured. ]

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2. Secondary:

Side Effects [ Time Frame: 8 weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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.

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Certain Agreements:  

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

Responsible Party:	Robert Schnoll, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00956943 History of Changes
Other Study ID Numbers:	809716; R21DA026889 ( U.S. NIH Grant/Contract )
First Submitted:	July 23, 2009
First Posted:	August 11, 2009
Results First Submitted:	January 14, 2013
Results First Posted:	March 18, 2013
Last Update Posted:	August 15, 2014