204
Participants
Start Date
December 14, 2015
Primary Completion Date
February 28, 2026
Study Completion Date
February 28, 2026
Varenicline
Varenicline Dosing: 0.5 mg/day by mouth for Days 1-3; 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter.
Nicotine Patch
Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.
Placebo Patch
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.
Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Questionnaires
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. Questionnaires should take about 30-45 minutes total to complete. On Days 17, 24, 38, and 73, done over the phone.
Counseling Sessions
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. These sessions take about 15 minutes each time.
Lab Session
Participant asked to watch slides. During the lab session, brain electrical activity checked with an electroencephalogram (EEG). Participant completes computer tasks, including questionnaires, that will measure emotions and attention level. These tasks should take about 90 minutes to complete. The lab session may last up to 2 hours.
Saliva Test
Saliva tested to check cotinine level at baseline, on Days 8 and 17, end of treatment visit, and at 3 months and 6 months after quitting smoking.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (2)
NAL PHARMA
OTHER
Pfizer
INDUSTRY
M.D. Anderson Cancer Center
OTHER