Daily Liraglutide For Nicotine Dependence
Brief Description Of Study
We are currently recruiting smokers who are interested in quitting for a research study that involves taking a medication called liraglutide. Liraglutide is also marketed under the name Saxenda®.
Liraglutide is an injectable medicine that may help some adults with who are overweight or obese lose weight and keep the weight off. Liraglutide is approved by the FDA for chronic weight management when combined with a reduced-calorie meal plan and physical activity. The use of liraglutide for smoking cessation in this study is investigational. Liraglutide comes in a pre-filled pen and is self-injected one time per day into the abdomen, thigh, or upper arm area. The needle used is very small; it is less than 1/4 of an inch long and as thin as two human hairs.
We are interested in seeing if liraglutide can help prevent weight gain during a quit attempt and if this helps people quit smoking. The purpose of this study is to determine the effectiveness of liraglutide in helping people quit smoking compared to placebo. The placebo is an inactive substance and is designed to look like the study drug but contains no medication. During the study, you will not know whether you are receiving the active study medication or the placebo.
Individuals who are eligible and decide to participate will receive the study medication (or placebo) and 8 sessions of smoking cessation counseling at no cost. Study participants will be compensated for time and travel. Participation in this study is completely voluntary and any information we collect about you will be kept confidential.
Detailed Study Description
This study is divided into two study periods: a 6-week Pre-Quit period when you prepare for your quit attempt, and a 6-month Monitoring period when we monitor how your quit attempt is going. Within each study period, you will be asked to take the study medication or placebo daily, undergo brief physiological assessments, complete questionnaires, provide biological samples such as blood and urine, and have your blood sugar monitored. You will also be asked to complete dietary recalls over the phone at different time points throughout the study. These recalls involve discussing what you ate and drank in a 24 hour period.
This study will involve 17 in-person visits to our center and 13 study phone calls. Most of these sessions will last 20 minutes to one hour; however, the two lab sessions may take up to 3 hours to complete. These two lab sessions will require you to abstain from smoking (meaning not smoke at all, even a puff) for 48 hours before the session. Participants must agree to not use any other smoking cessation medications or nicotine replacement therapy other than what is provided during the study.
ClinicalTrials.gov Identifier: NCT03712098