Trial Outcomes & Findings for Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine (NCT NCT00956943)

Results Overview

quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

After 8 weeks of treatment with the patch, outcome will be measured.

Results posted on

2014-08-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	43	44
Overall Study Baseline	43	44
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	9	10

Baseline Characteristics

Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	21mg Transdermal Nicotine + Placebo Patch n=43 Participants	42mg Transdermal Nicotine n=44 Participants	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=93 Participants	44 Participants n=4 Participants	87 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 9.0 • n=93 Participants	38.8 years STANDARD_DEVIATION 9.0 • n=4 Participants	38 years STANDARD_DEVIATION 9 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	23 Participants n=4 Participants	45 Participants n=27 Participants
Sex: Female, Male Male	21 Participants n=93 Participants	21 Participants n=4 Participants	42 Participants n=27 Participants
Region of Enrollment United States	43 participants n=93 Participants	44 participants n=4 Participants	87 participants n=27 Participants

PRIMARY outcome

Timeframe: After 8 weeks of treatment with the patch, outcome will be measured.

Population: intent to treat

quit rate verified with carbon monoxide breath sample (abstinence: less than or equal to 10ppm)

Outcome measures

Outcome measures
Measure	21mg Transdermal Nicotine + Placebo Patch n=43 Participants 21mg transdermal nicotine + placebo patch Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks placebo : placebo patch	42mg Transdermal Nicotine n=44 Participants 42mg transdermal nicotine Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
Biochemically Verified 7-day Point Prevalence Abstinence at the End of 8 Weeks of Treatment	10 participants	13 participants

SECONDARY outcome

Timeframe: 8 weeks

Population: intent to treat

frequency of serious adverse events

Outcome measures

Outcome measures
Measure	21mg Transdermal Nicotine + Placebo Patch n=43 Participants 21mg transdermal nicotine + placebo patch Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks placebo : placebo patch	42mg Transdermal Nicotine n=44 Participants 42mg transdermal nicotine Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
Side Effects	0 events	1 events

Adverse Events

21mg Transdermal Nicotine + Placebo Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

42mg Transdermal Nicotine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	21mg Transdermal Nicotine + Placebo Patch n=43 participants at risk 21mg transdermal nicotine + placebo patch Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks placebo : placebo patch	42mg Transdermal Nicotine n=44 participants at risk 42mg transdermal nicotine Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks
Infections and infestations influenza	0.00% 0/43 • 8 weeks	2.3% 1/44 • Number of events 1 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Robert A. Schnoll, Ph.D.

University of Pennsylvania

Phone: 215-746-7143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place