Clinical Trial to Test Smoking-Cessation Investigational Medication

CINCINNATI—A clinical trial currently enrolling volunteers at the University of Cincinnati (UC) will test a novel smoking-cessation investigational medication for women who want to break the habit.

AstraZeneca, a multinational pharmaceutical company with headquarters in London, is partnering with the National Institute on Drug Abuse (NIDA) to conduct the phase-2 trial, in which an investigational drug is tested for effectiveness and evaluated for safety.  The investigational drug, known as AZD8529, is taken orally in pill form.

UC is one of nine sites nationwide that were selected to participate in the trial. The principal investigator at UC is Theresa Winhusen, PhD, a professor in the Department of Psychiatry and Behavioral Neuroscience and director of the department’s Addiction Sciences Division. Co-directing the study is Anne Autry, MD, a UC Health physician working in the field of substance abuse.

Winhusen says three types of smoking-cessation pharmacotherapy are currently approved by the U.S. Food and Drug Administration, but none works with the same mechanism as AZD8529.

"While these medications significantly increase smoking-cessation rates during the time they are utilized, relapse to smoking is common, with less than 25 percent abstinence rates at one year even with follow-up and behavioral support,” Winhusen says.

"AZD8529 has a different mechanism of action from the currently approved medications,” Winhusen says. "It modulates a type of glutamate receptor to inhibit the excessive release of glutamate, a neurotransmitter which research suggests plays a role in nicotine dependence.”

Additionally, Winhusen says, the investigational medication being tested has a selective mechanism of action, which could  translate into fewer side effects, and it works in areas of the brain that are important for addiction.

Earlier this month, the U.S. Centers for Disease Control and Prevention reported that the U.S. smoking rate is just over 15 percent of adults reporting they're current smokers. That's down from nearly 17 percent in 2014 and almost 18 percent in 2013. Still Winhusen says, smoking is a major health concern.

"Each year, smoking kills nearly 450,000 people in the United States and costs more than $100 billion in health care costs and productivity losses,” she says. "It’s important to develop strategies to continue to drive the smoking rate downward.”

In the study, volunteers will be randomly assigned to two different doses of AZD8529, one of which is a very low dose.

Researchers are enrolling women between 18 and 75 years old who smoke 10 or more cigarettes a day and want to quit smoking. The trial is limited to women because animal studies found some negative effects on male reproductive organs, while there were no changes in female reproductive organs.

Participants should be generally healthy and not pregnant or breastfeeding, and they should not have used other tobacco products or any alternatives to cigarettes such as gum, patches or medications in the past 30 days.

Study participation lasts about 19 weeks, with about 14 clinic visits plus three eye exam visits. The study is being conducted at the UC Health Addiction Sciences clinic, 3131 Harvey Ave., which is part of the UC medical campus. All participants will receive nine brief smoking-cessation counseling sessions without cost.

All assessments associated with the study are without cost, and participants will be compensated for their time.   

>> Additional information about the trial