Trial Outcomes & Findings for Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT) (NCT NCT00326781)

Results Overview

A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

674 participants

Primary outcome timeframe

End of Treatment (8-weeks after quit date)

Results posted on

2010-08-24

Participant Flow

Recruitment occurred between December 1999 and July 2003.

Participant milestones

Participant milestones
Measure	Transdermal Nicotine Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.	Nicotine Nasal Spray Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
Overall Study STARTED	344	330
Overall Study COMPLETED	302	298
Overall Study NOT COMPLETED	42	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transdermal Nicotine n=344 Participants Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.	Nicotine Nasal Spray n=330 Participants Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.	Total n=674 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	329 Participants n=5 Participants	321 Participants n=7 Participants	650 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	9 Participants n=7 Participants	24 Participants n=5 Participants
Age Continuous	45.63 years STANDARD_DEVIATION 10.88 • n=5 Participants	45.41 years STANDARD_DEVIATION 10.37 • n=7 Participants	45.53 years STANDARD_DEVIATION 10.63 • n=5 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	185 Participants n=7 Participants	359 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	145 Participants n=7 Participants	315 Participants n=5 Participants
Region of Enrollment United States	344 participants n=5 Participants	330 participants n=7 Participants	674 participants n=5 Participants

PRIMARY outcome

Timeframe: End of Treatment (8-weeks after quit date)

Population: Analysis was intention to treat (ITT)

A self-report measure of continuous abstinence at end of treatment. It is defined as the number of consecutive days without smoking a cigarette for each subject, as determined by the Timeline Followback (TLFB), completed by research staff. The TLFB is an assessment tool that obtains estimates of daily smoking. Using a calendar, people provide retrospective estimates of their daily smoking over a specified time period that can vary up to 12 months from the interview date. The TLFB has also been used to assess other forms of substance abuse (e.g., alcohol, drugs, etc.).

Outcome measures

Outcome measures
Measure	Transdermal Nicotine n=344 Participants Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.	Nicotine Nasal Spray n=330 Participants Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)	83 Participants	75 Participants

SECONDARY outcome

Timeframe: End of Treatment

End-of-Treatment (EOT) is defined as the phone survey that takes place at the end of each subject's nicotine replacement therapy treatment. The EOT took place up to 8 weeks after participants began the study and also utilized the Timeline Followback. It is a 7-day point prevalence measure describing a subject's ability to remain abstinent from smoking for the 7 previous days occurring before a subject's EOT phone survey. This was verified by a Carbon Monoxide breath reading taking place within a week of a subject's End of Treatment phone survey.

Outcome measures

Outcome measures
Measure	Transdermal Nicotine n=344 Participants Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.	Nicotine Nasal Spray n=330 Participants Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
Verified 7-day Point Prevalence Abstinence at End Of Treatment.	112 participants	95 participants

Adverse Events

Transdermal Nicotine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nicotine Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Caryn Lerman, Ph.D.

University of Pennsylvania

Phone: 215-746-7141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place