Smoking
Conditions
Keywords
Nicotine nasal spray + counseling, Transdermal nicotine + counseling
Brief summary
The purpose of this research study is to: 1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking cessation; and 2. identify predictors of response to these alternate forms of nicotine replacement therapy (NRT).
Detailed description
The ultimate objective is to obtain information necessary to match NRT to those smokers with the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine nasal spray (NS) will result in significantly higher abstinence rates than transdermal nicotine (TN) for the following subgroups of smokers: those with genotypes associated with less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with higher levels of novelty-seeking, depression, and attention deficit symptoms.
Interventions
DRUGNicoderm Transdermal Patch
The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.
8 weeks of self-administered nicotine nasal spray at 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. Treatment lasted 8 weeks.
Sponsors
National Cancer Institute (NCI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* The subjects will be male and female smokers age 18-75. * Eligible smokers will be those currently smoking at least 10 cigarettes a day.
Exclusion criteria
* Planning a pregnancy, pregnant, or lactating * Current addiction to opiates, cocaine, or stimulants * Skin allergies or chronic dermatitis (based on medical history/self-report) * An Axis 1 major psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | End of Treatment (8-weeks after quit date) | 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.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verified 7-day Point Prevalence Abstinence at End Of Treatment. | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between December 1999 and July 2003.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 344 |
| 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. | 330 |
| Total | 674 |
Baseline characteristics
| Characteristic | Nicotine Nasal Spray | Transdermal Nicotine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 15 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 321 Participants | 329 Participants | 650 Participants |
| Age Continuous | 45.41 years STANDARD_DEVIATION 10.37 | 45.63 years STANDARD_DEVIATION 10.88 | 45.53 years STANDARD_DEVIATION 10.63 |
| Region of Enrollment United States | 330 participants | 344 participants | 674 participants |
| Sex: Female, Male Female | 185 Participants | 174 Participants | 359 Participants |
| Sex: Female, Male Male | 145 Participants | 170 Participants | 315 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 344 | 0 / 330 |
| serious Total, serious adverse events | 0 / 344 | 0 / 330 |
Outcome results
Primary
Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject)
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.).
Time frame: End of Treatment (8-weeks after quit date)
Population: Analysis was intention to treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transdermal Nicotine | Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | 83 Participants |
| Nicotine Nasal Spray | Continuous Abstinence at End of Treatment (Self-report)(Defined as the Number of Consecutive Days Without Smoking a Cigarette for Each Subject) | 75 Participants |
Secondary
Verified 7-day Point Prevalence Abstinence at 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.
Time frame: End of Treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Transdermal Nicotine | Verified 7-day Point Prevalence Abstinence at End Of Treatment. | 112 participants |
| Nicotine Nasal Spray | Verified 7-day Point Prevalence Abstinence at End Of Treatment. | 95 participants |