Varenicline + Guanfacine for Smoking Cessation
What You Need to Know Before You Apply
What is the purpose of this trial?
The novel design of this study combines a laboratory paradigm to evaluate stress-induced smoking behavior and smoking-related reinforcement, followed by a 12-week treatment phase to evaluate clinical outcomes.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications known to be effective for smoking cessation and certain other medications like antihypertensives and CNS depressants. If you're on these, you may need to stop them to participate.
Is the combination of Varenicline and Guanfacine safe for smoking cessation?
What makes the drug combination of Varenicline and Guanfacine unique for smoking cessation?
The combination of Varenicline and Guanfacine for smoking cessation is unique because Varenicline is a partial agonist that targets specific nicotine receptors to reduce cravings and withdrawal symptoms, while Guanfacine, typically used for ADHD and hypertension, may help manage stress and impulse control, potentially enhancing the effectiveness of smoking cessation efforts.13567
What data supports the effectiveness of the drug Varenicline for smoking cessation?
Varenicline has been shown to be effective in helping people quit smoking, with studies indicating that it significantly increases the chances of long-term abstinence compared to a placebo or another smoking cessation drug, bupropion. It works by reducing withdrawal symptoms and the urge to smoke, making it a valuable option for those looking to quit smoking.3891011
Who Is on the Research Team?
Sherry McKee, PhD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for adults who've smoked 10+ cigarettes daily for the past year, have a CO level >10 ppm, are motivated to quit smoking, and can commit to the study duration. They must be stable residents with transport and no plans to move soon. Excluded are those with significant medical conditions, substance use disorders (except mild alcohol/tobacco), recent psychoactive drug use, severe mental illness or ADHD.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Titration
Participants titrate to steady state levels of Varenicline and Guanfacine
Treatment
Participants receive Varenicline and Guanfacine for smoking cessation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Guanfacine ER
- Varenicline
Guanfacine ER is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator