Altoona Arthritis & Osteoporosis Center, the Altoona Center for Clinical Research Participating in ORCA-3

Altoona Arthritis and Osteoporosis Center and the Altoona Center for Clinical Research is enrolling eligible volunteers into ORCA-3, a U.S. Phase 3 clinical research study evaluating the safety and efficacy of cytisinicline, an investigational therapy for smoking cessation. ORCA-3 is seeking to enroll adults who smoke 10 or more cigarettes per day, intend to quit smoking, and have failed at least one previous attempt to stop smoking with or without therapeutic support.

A recent report showed that in 2020, for the first time in 20 years, there was an increase in cigarette purchases. Despite the clearly defined health risks associated with cigarette smoking, it is estimated that there are 34 million adults who are current cigarette smokers. Prescription medication and counseling have been shown to improve quit rates, yet are used by a minority of those trying to quit. Among the 68 percent of smokers who want to quit, less than 7 percent reported using counseling and only 29 percent reported using pharmacotherapy, and less than 5 percent used both.

Cytisinicline

Cytisinicline is a plant-based, naturally-occurring investigational compound that is structurally similar to nicotine and is believed to aid in smoking cessation by binding more specifically to a certain nicotinic receptor in the brain. This binding partially stimulates dopamine release, which reduces nicotine cravings and the severity of nicotine withdrawal symptoms. It also directly inhibits nicotine binding, reducing the satisfaction typically associated with smoking.

The FDA-approved non-nicotine-containing smoking cessation therapies, varenicline and bupropion, can improve rates of smoking cessation, but they are associated with troublesome side effects. Additional treatment options are needed to help more people successfully quit smoking and reduce their smoking-related health risks. While the benefits of quitting cigarette smoking are well understood in both the medical and consumer communities, it is encouraged that cigarette smokers make quitting a resolution for 2022 and to speak with their healthcare providers about options that can help them succeed, including potential clinical trial participation when appropriate.

ORCA-3

ORCA-3 is being conducted to learn more about the effectiveness and safety of cytisinicline in combination with behavioral support in people trying to quit cigarette smoking. In this study, researchers want to find out if cytisinicline with behavioral support can increase the probability of abstaining from cigarette smoking. The study will also assess the safety and tolerability profile of cytisinicline.

Altoona Arthritis & Osteoporosis Center and the Altoona Center for Clinical Research is one of many clinical sites participating in ORCA-3. The study is open to adults at least 18 years of age. Participants must be willing to set a quit date within 5-7 days of starting treatment and be willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study. Subjects participating in the study will receive study medication and study-related care at no cost and will be reimbursed for study-related travel expenses.

An independent Institutional Review Board (IRB) has also approved the study for enrollment.

If you or someone you know is interested in joining the study, please call (814) 693-0300 ext. 188.