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ASU leads Arizona site for a clinical trial on smoking cessation drug

Current findings show very few side effects to be associated with taking cytisinicline, a naturally occurring smoking cessation, compared to existing drugs

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"The drug helps replace nicotine as the trigger for dopamine, replacing the urge to smoke." Illustration published on Monday, March 29, 2021.

A plant-based medication may be the solution to nicotine and cigarette addiction, and an ASU professor is helping lead the study.

Scott Leischow, director and professor at the College of Health Solutions, is heading the Arizona site for a clinical trial on the naturally occurring smoking cessation drug cytisinicline.

Achieve Life Sciences, a pharmaceutical company dedicated entirely to researching cytisinicline as it works to stop nicotine and tobacco addiction, has a clinical site on ASU's Downtown Phoenix campus.

According to Achieve Life Sciences CEO John Bencich, the Phase 3 ORCA-2 clinical trial is being run across 15 centers around the U.S. and the company hopes to enroll 750 participants in the 12-week trial. Leischow said people are paid up to $1,950 as compensation for participating in the study as long as they come in for the visits. Participants are also provided with counseling. 

Rick Stewart, co-founder and chairman of the board of directors at Achieve Life Sciences, said the company noticed the drug's success among around 15 million people in Bulgaria. He said the company is currently deriving the drug from the seeds of laburnum trees in Bulgaria.

"The fact that it is naturally derived is a real advantage," Stewart said. "I think there's a great skepticism in some parts about synthetic chemicals."

The ongoing clinical trial, Stewart said, is not the first one Achieve Life Sciences has conducted in studying the smoking cessation drug. The company has also received funding from the National Institutes of Health for non-clinical studies in the U.S.

For drug manufacturing, Bencich said the company partnered with Bulgarian drug manufacturer Sopharma AD.

"It became a great opportunity where we could go take this drug to the rest of the world and they could continue to focus on selling it into their markets," Bencich said.

Data from the Centers for Disease Control and Prevention from 2020 shows "smoking is the leading cause of preventable death." 

"Even though we're in the midst of a pandemic, smoking and tobacco-related issues are really a public health epidemic that continues in the backdrop," Bencich said. 

He said the main focus for Achieve Life Sciences is getting people off of combustible cigarettes, but the company plans to expand into treatment for quitting e-cigarettes and vape devices.

According to Leischow, the drug helps reduce cravings and withdrawal symptoms by triggering the same specific receptors in the brain as nicotine. When these receptors are stimulated, they trigger the release of dopamine in the frontal areas of the brain. The drug helps replace nicotine as the trigger for dopamine.

Leischow also said current findings show very few side effects to be associated with taking cytisinicline, compared to other existing smoking cessation drugs.

Chantix, the popular smoking cessation drug patented by Pfizer, was based on cytisinicline, but Leischow said it was likely not adopted by Pfizer due to the inability to patent naturally occurring substances.

"Companies typically want to move into and develop a product that they can patent because then they have exclusive rights to it for many years," Leischow said. 

Bencich said, however, that Achieve Life Sciences has been, "building up families of patents around formulation, method of use, as well as the extraction process."

Bencich said one of the problems with varenicline, the generic name of Chantix, is that it hits a couple of targets outside of the nicotine receptors in the brain, which causes higher rates of side effects such as sleep disturbance, nausea and headaches. 

A 2021 study published by Achieve Life Sciences found that subjects who used cytisinicline were 55% more likely to quit smoking as opposed to those who used varenicline. There were also fewer side effects, the study found.

People who are interested in participating in the study at ASU's Downtown Phoenix campus can visit or call 775-476-2360.

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