The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy will show significantly higher biochemically confirmed 30-day continuous abstinence at 12 weeks post-Target Quit Day (TQD).
The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies (Varenicline and Nicotine Patch). The adaptive treatment approach provides the addition of Bupropion in the pre-quit period for participants who are not "responding" to initial treatment. Little is known about the adaptive use of Varenicline or Nicotine Patch, in which Bupropion is added to Varenicline or Patch for those who do not respond to one of these medications in a pre-quit treatment period. This study attempts to address these knowledge deficits. The study (N=300) is a double-blinded randomized placebo-controlled trial designed to compare biochemically-confirmed abstinence rates in smokers randomized to Varenicline Adaptive Protocol vs. Varenicline (N=150) and for comparison, Nicotine Patch Adaptive Protocol vs. Nicotine Patch (N=150). The "Varenicline Adaptive Protocol" is conducted by starting treatment with Varenicline 4 weeks prior to the quit day and following each participant's response to this pre-treatment medication. After 2 weeks, if the patient shows a reduction greater than 50% in cigarettes smoked per day, then the patient is considered to be a "Varenicline responder" and is continued on Varenicline alone out to 12-weeks post quit day. If the patient does not spontaneously decrease smoking in the pre-quit period by more than 50% cigarettes per day, the patient is considered to be a "Varenicline non-responder" and Bupropion is added to the Varenicline. For comparison, an identical protocol is used with nicotine patch vs. nicotine patch adaptive treatment. The study uses only FDA-approved medications: Varenicline, Nicotine Patch, Bupropion, and placebo controls. To pattern clinical practice, participants will be able to choose whether they would like to use a patch or Varenicline-based treatment. After choosing, however, they will be randomized to adaptive vs. non-adaptive version of that treatment. Placebo medications are matched throughout the study. Participants will be blinded to all medications. All participants will receive behavioral treatment including a single 40-minute visit with a medical provider. The study is designed to provide researchers and clinicians with a better understanding of how to use adaptive pharmacotherapy protocols to improve smoking cessation rates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
188
4 weeks pre-TQD: Start Placebo Varenicline 1 week prior to TQD: Switch to Active Varenicline 1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD
4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch 1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD
VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by \> 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by \> 50% 1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Biochemically-confirmed 30-day Continuous Smoking Abstinence
Number of participants who self report complete smoking abstinence over the last 30 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO \< 7 parts per million.
Time frame: 12 weeks post-TQD (Visit 4)
7-day Point Prevalence Biochemically Confirmed Abstinence
Number of participants who self report complete smoking abstinence over the last 7 days and are also verified to be abstinent by carbon monoxide (CO) expired breath testing with CO \< 7 parts per million.
Time frame: 12 weeks post-TQD (Visit 4)
Phone-assessed Self-reported Abstinence
Number of participants who self reported smoking abstinence over the last 24 hours assessed via single-item question.
Time frame: 52 weeks post-TQD
Change in Cigarettes Smoked Per Day
The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 12 weeks post target quit day assessment visit collected by self-report in participants who completed the 12-week post target quit day assessment visit
Time frame: 12 weeks post-TQD (Visit 4)
Change in Cigarettes Smoked Per Day (Phone)
The percentage of participants who decreased the number of daily cigarettes smoked by 50% or more from the baseline assessment visit to 52 weeks post target quit day assessment visit collected by self-report in participants who completed the 52-week post target quit day phone assessment.
Time frame: 52 weeks post-TQD
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NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by \> 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by \> 50% 1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD