Type 2 Diabetes – Using one weekly Insulin Injection
Intend Research is participating in ORCA-3, a multicenter, double-blind, randomized, placebo-controlled phase 3 trial evaluating the efficacy and safety of cytisinicline in adult smokers.
ORCA-3 is being conducted to assess the effectiveness and safety of cytisinicline as a smoking cessation therapy in adults who smoke cigarettes. Cytisinicline is a naturally occurring, plant-based investigational treatment that is believed to aid in smoking cessation by reducing the severity of nicotine withdrawal symptoms.
To qualify for ORCA-3, participants must (be/have):
· Age ≥18 years
· Current daily cigarette smokers who smoke ten or more cigarettes per day and who intend to quit smoking
· Failed at least one previous attempt to stop smoking with or without therapeutic support
· Willing to set a quit date within 5-7 days of starting treatment
· Willing to actively participate in the study’s smoking cessation behavioral support provided throughout the study
· Doctors will check other requirements to confirm that participants qualify for this study.
Participants will be randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytisinicline administered for either 6 or 12 weeks, compared to placebo. All participants will receive standard behavioral support and will be assigned to one of the following groups:
· Arm A: 12 weeks of placebo
· Arm B: 6 weeks of cytisinicline, followed by 6 weeks of placebo
· Arm C: 12 weeks of cytisinicline
If participants qualify for and enroll in this study, they may receive the following:
· Cytisinicline (study drug), or placebo
· Study-related medical tests
· Financial stipend to help with travel costs and time
All study medication and study-related care will be at no cost.
If you or someone you know is interested in joining the study, or would like to learn more, please call 405-701-8999.
