Luba Yammine, left, and Joy Schmitz lead the clinical study. (Rob Cahill, University of Texas Health Science Center)
1 May 2019. A clinical trial began enrolling participants to test the ability of a drug approved for treating diabetes, to also help people stop smoking cigarettes. The trial is conducted by University of Texas Health Science Center in Houston, a joint project of the institution’s nursing and behavioral science departments.
Cigarette smoking continues to be a leading U.S. public health problem. Centers for Disease Control and Prevention says smoking leads to some 480,000 deaths a year, or 1 in every 5 deaths in the U.S. Cigarettes harm most every organ in the body, says CDC, are the cause of many diseases, and reduce the overall health of smokers. And the agency says more than 10 times the number of Americans died prematurely from cigarette smoking than in all of the wars fought by the U.S. in its history.
Yet stopping the use of cigarettes remains difficult. Breaking a dependence on nicotine and tobacco often requires considerable efforts by smokers, repeated treatments, and an extended period of time. “Effective treatments for smoking cessation exist, but we still see a high rate of relapse,” says Joy Schmitz, professor of psychiatry and behavioral science, and one of the project leaders in a UT-Health Science Center statement.
The team led by Schmitz and nursing school professor Luba Yammine is testing the drug exenatide, approved by FDA as a treatment for type 2 diabetes, usually with other medications as well as changes in diet and exercise. Exenatide is a type of drug called glucagon-like peptide 1, or GLP-1 receptor agonists that activate GLP-1 peptides to promote production of insulin in the pancreas. The drug is given as a self-administered injection under the skin with a pen-like device, and prescribed as a supplemental treatment for people who need extra help controlling their blood glucose levels beyond diet, exercise, and first-line treatments.
Yammine notes that evidence from preclinical and clinical studies shows “exenatide can decrease consumption of food and other addictive substances such as alcohol and nicotine.” She adds, “We think that this drug will help with smoking cessation through the mechanism of reward. People will experience less enjoyment when they smoke. It may also help to decrease cravings for cigarettes and withdrawal symptoms that people may experience when they try to quit smoking.”
The early- and mid-stage clinical trial is recruiting 90 adult participants at UT-Health Science Center who both smoke cigarettes but want to quit, and are overweight or have prediabetic blood glucose levels. All participants are given nicotine-replacement therapy patches, but then randomly assigned to received weekly exenatide injections with the drug Bydureon made by AstraZeneca, or a placebo injection for 6 weeks.
Participants are assessed every week at weeks 3 to 6 for smoking abstinence by self-reporting and carbon monoxide in their exhaled breath, an indicator of cigarette use, as well as questionnaires on withdrawal symptoms and cigarette cravings. Participants will then be tracked for another 4 weeks.
“Tobacco use remains the leading cause of preventable death,” notes Schmitz. “Exenatide targets a different mechanism of action that holds promise for pharmacological treatment of smoking and possibly other addictive behaviors.”
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