Varenicline (Chantix®/Champix®) was approved as an "aid to smoking cessation treatment" in adults by the FDA in May 2006, and for "smoking cessation in adults" by the EMEA in September 2006. The drug not only produces partial activation at nicotine receptors which eases craving and withdrawal symptoms, but it also blocks the effects of nicotine from cigarettes, reducing the satisfaction of smoking. The approved dose regimen is 1.0mg twice daily (1mg BID) for 12 weeks with a one-week titration period at the start of treatment. The maintenance of Abstinence study has assessed the effect of an additional 12 weeks of treatment on likelihood of long-term abstinence. Based on results, for patients who have successfully stopped after 12 weeks, an additional course of 12 weeks treatment is recommended.
The effectiveness of Chantix re-treatment has not previously been studied in clinical trials. Thus, our current study (“A Phase 4 Randomized Double-blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline”) aims to compare the effects of the study drug, Chantix, with a placebo to find out which is better for helping smokers to quit when they have previously not been able to quit or relapsed to smoking when using Chantix in the past.
There will be a total of 490 participants at 30 sites across 8 countries; our Center will be responsible for up to 25 of those participants. Participants are randomized to either take Chantix or placebo at a dose of 1.0mg twice a day for 12 weeks with a one-week titration period. Participants will be in the study for approximately one year and will visit the University of Maryland 19 times over the course of a year for clinical assessments as well as individualized smoking cessation counseling to help with the quitting process. Behavioral counseling sessions are offered throughout the entire duration of the study to help participants maintain a smoke-free status or to continue to assist participants that are having trouble quitting. The University of Maryland enrolled its first subject in late February of 2011; the study is expected to continue throughout the next year.
This study is being funded by Pfizer.
Hookah, or waterpipe, use is widely practiced in the Middle East and North Africa and is rapidly gaining popularity in the US and Europe. There is a misconception that hookah is less harmful than cigarette smoking. Our preliminary work reveals that carbon monoxide levels generated during a typical hookah session are about 10-fold levels generated by smoking a cigarette.
We have now developed standardized techniques for measuring human exposure and machine-smoked emissions from hookah. The study, which is currently in progress, is funded by the National Institutes of Health and scheduled for completion Fall 2011.
And Coming Up...
Abuse liability assessment and characterization of an electronic nicotine delivery device
Electronic nicotine delivery systems (ENDS), also known as electronic cigarettes, are promoted as alternatives to cigarettes, but also as smoking cessation aids. ENDS are nicotine “atomizers” that look like cigarettes and deliver nicotine to the respiratory tract. Thus far, scientific evidence has not been available to establish sufficient cessation efficacy and safety. Electronic nicotine delivery systems may or may not be acceptable cessation aids.
The National Institute of Drug Abuse recently awarded the Center an R21 grant to carry out a study targeting this questioned efficacy and safety of electronic nicotine delivery devices as smoking cessation aids under the direction of Dr. Pamela Clark. As indicated by the study’s title, “Abuse liability assessment and characterization of an electronic nicotine delivery device,” the Center will be focusing on the potential role of ENDS as pharmacobehavioral treatment in the field of smoking cessation. The study should commence at some point during the fall of 2011.