125
Participants
Start Date
January 31, 2016
Primary Completion Date
January 7, 2019
Study Completion Date
January 7, 2019
Nicotine Patch
Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
Varenicline
Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
Placebo Nicotine Patch
"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the VAR group, participants will wear a placebo patch while taking varenicline."
Placebo Capsule
"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
Duke Medical Center, Durham
Lead Sponsor
National Institutes of Health (NIH)
NIH
National Institute on Drug Abuse (NIDA)
NIH
Duke University
OTHER