Varenicline + NRT for Smoking Cessation
Trial Summary
What is the purpose of this trial?
This randomized pilot phase IV trial studies the side effects and how well varenicline works compared to nicotine replacement therapy in helping patients that smoke to quit. Varenicline is a drug that acts the same way as nicotine in the brain but is not habit-forming. Nicotine replacement therapy consists of nicotine patches and lozenges. It is not yet known if varenicline is more effective than nicotine replacement therapy in helping patients quit smoking.
Do I need to stop taking my current medications to join the trial?
The trial requires you to stop using certain smoking cessation medications like Wellbutrin, Bupropion, Zyban, nicotine replacement therapy, and Chantix at least 7 days before joining. If you are taking certain depression medications like MAOIs or Elavil, you need to stop 14 days before. Other medications will be evaluated on a case-by-case basis by the study physician.
What data supports the effectiveness of the drug Varenicline combined with Nicotine Replacement Therapy for smoking cessation?
Research shows that Varenicline, known as Chantix, is effective for quitting smoking, with higher success rates compared to other treatments like bupropion and placebo. Additionally, both Varenicline and combination nicotine replacement therapy (cNRT) are recommended as effective options for smoking cessation, with similar success rates in helping people quit smoking.12345
Is the combination of Varenicline and Nicotine Replacement Therapy (NRT) safe for smoking cessation?
Varenicline, known as Chantix or Champix, has been associated with some safety concerns, including potential neuropsychiatric side effects like depression and suicidal thoughts, as well as interactions with alcohol. While it is effective for smoking cessation, these risks should be discussed with a healthcare provider.16789
What makes the drug Varenicline unique for smoking cessation?
Research Team
Jason Robinson
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, are interested in quitting, and can follow instructions in English. They must not use other tobacco products frequently or be on certain medications like smoking cessation drugs or some antidepressants. People with severe kidney or liver disease, uncontrolled high blood pressure, recent heart issues, or unstable psychiatric conditions cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either varenicline or nicotine replacement therapy for smoking cessation, with behavioral counseling over 12 weeks
Re-randomization and Additional Treatment
Participants who fail to achieve abstinence at week 6 are re-randomized to receive 6 additional weeks of therapy, either continuing the same treatment, switching to the other treatment, or receiving a high-dose version
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nicotine Lozenge
- Nicotine Patch
- Varenicline
Varenicline is already approved in United States, European Union, Canada for the following indications:
- Smoking cessation
- Dry eye disease
- Smoking cessation
- Smoking cessation
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator