Smoking Cessation Medications for Smoking Addiction
What You Need to Know Before You Apply
What is the purpose of this trial?
This project will use the Multiphase Optimization Strategy (MOST) to guide the development of optimized treatment strategies for the two most effective smoking cessation medications (Combination Nicotine Replacement \[C-NRT\] and varenicline). The investigators will recruit daily smokers from primary care to participate in a fully crossed, 2x2x2x2 factorial experiment (N=608) that evaluates 4 different factors: 1) Medication Type (Varenicline vs. C-NRT), 2) Preparation Medication (4 Weeks vs. Standard), 3) Medication Duration (Extended \[24 weeks\] vs. Standard \[12 weeks\]); and 4) Counseling (Intensive vs. Minimal). Participants will complete assessments one week pre-quit and then assessments of smoking status, treatment use, side effects, potential treatment mechanisms (e.g., withdrawal, self-efficacy) during the first week post-target quit date (TQD) and at Weeks 2, 4, 12, 20, 26, and 52 post-target quit date. These data will be used to examine the main and interactive effects of these four factors on various outcomes, with biochemically confirmed 12-month abstinence serving as the primary outcome. These data will also be used to determine which factors and combinations of factors are most effective with regard to 12-month biochemically confirmed abstinence and cost, thereby identifying optimized varenicline and C-NRT treatments, with each developed to yield especially great benefit. These optimized treatments will then be tested in the Optimized Care Project. The investigators will also examine the relative effects of each medication on particular outcomes (e.g., 12-month abstinence).
Will I have to stop taking my current medications?
If you are currently using nicotine replacement therapy (NRT), you will need to switch to the study medication for the duration of the trial. If you are taking bupropion or varenicline, you cannot participate in the trial.
Is varenicline safe for humans?
Varenicline, used to help people stop smoking, has been linked to some serious mental health side effects like depression and suicidal thoughts. While it can be effective in reducing cravings, it's important to discuss the potential risks with a healthcare provider before starting the medication.12345
How is the drug combination of Nicotine Replacement Therapy and Varenicline unique for smoking cessation?
This treatment is unique because it combines Nicotine Replacement Therapy with Varenicline, a novel drug that acts as a partial agonist on specific brain receptors, helping to reduce cravings and withdrawal symptoms while blocking the rewarding effects of smoking. Varenicline's targeted mechanism of action and its ability to stimulate dopamine release while blocking nicotine receptors make it a promising option compared to other available therapies.678910
What data supports the effectiveness of the drug Varenicline for smoking cessation?
Who Is on the Research Team?
Megan E Piper, PhD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for daily smokers who've been smoking more than 4 cigarettes a day for the past 6 months, can use study medications safely, and if female and able to have children, must be using birth control. Smokers already on bupropion or varenicline or with recent suicidal thoughts or attempts cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Participants receive preparation medication and counseling prior to the target quit day (TQD)
Treatment
Participants receive either Varenicline or C-NRT with counseling, starting on the target quit day (TQD)
Follow-up
Participants are monitored for smoking status, treatment use, and side effects
What Are the Treatments Tested in This Trial?
Interventions
- Combination Nicotine Replacement Therapy
- Intensive Counseling
- Minimal Counseling
- Varenicline
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Cancer Institute (NCI)
Collaborator