The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone.
Cigarette smokers, who are motivated to quit smoking but who rate the inhalation aspects of smoking as important will be randomized to three groups: Group 1. Nicotine ENDS + nicotine patch; Group 2: Nicotine ENDS + placebo patch; Group 3: Placebo ENDS + Nicotine patch. Participants will initially receive 1 week of 21 mg nicotine (or placebo) skin patches while continuing to smoke their usual cigarettes ad lib, in order to assess responsiveness to Nicotine Replacement Therapy (NRT). Starting with week 2, participants will receive nicotine-containing (or placebo) ENDS devices (menthol or non-menthol versions in accordance with their baseline preference). They will also be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Continuous four-week abstinence from smoking during treatment
The primary outcome measure will be continuous four-week abstinence from smoking during weeks 4-8 post target Quit Day while treatment is ongoing. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) \<10 ppm (measured at Week 8). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Time frame: Weeks 4-8 post target Quit Day
Continuous four-week abstinence from smoking after withdrawal of ENDS
A secondary outcome measure will be continuous four-week abstinence from smoking during weeks 9-12 post target Quit Day while participants are decreasing their use of ENDS. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) \<10 ppm (measured at Week 12). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Time frame: Weeks 9-12 post target Quit Day
Continuous four-week abstinence from smoking after withdrawal of nicotine patches
A secondary outcome measure will be continuous four-week abstinence from smoking during weeks 13-16 post target Quit Day while participants are using decreasing doses of nicotine patches. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) \<10 ppm (measured at Week 16). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Time frame: Weeks 13-16 post target Quit Day
Seven-day point abstinence from smoking at 6 months post Quit Day
A secondary outcome measure will be seven-day abstinence from smoking at six months post target Quit Day. This will be determined by self-report of no smoking for the previous seven days when called for 6-month follow-up, verified by expired air carbon monoxide (CO) \<10 ppm (measured at 6-month follow-up visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
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As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
Time frame: 6 months post Quit Day