Am I eligible to participate in the ORCA-V1 study?
To qualify for further evaluation to participate in the study, you must meet the following:
Be at least 18 years of age and generally in good health
Currently use e-cigarettes daily and not currently smoking combustible cigarettes
Intend to quit vaping and be willing to set a quit date within 7-14 days of starting treatment
Have access to a smartphone, tablet, or computer
Willing to complete assessments on vaping abstinence on a weekly basis with self-reported abstinence as well as verification by biochemical testing using quantitative saliva cotinine levels at each weekly assessment
Willing to attend at least 1 clinic visit for eligibility screening, and if selected, be willing to visit the clinical trial site every week for 12 weeks and then one month later for follow up
Willing to actively participate in the study’s vaping cessation behavioral support provided throughout the study
To confirm you qualify for the study, study doctors will test and verify additional requirements for participation.
Why should I participate in this study?
While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals that can cause lung injury or cardiovascular disease. 1
The long-term safety of nicotine e-cigarettes remains controversial, and most experts concur that there is a significant unmet need for safe and effective cessation aids.
Prescription medication and counseling, when used together, have been shown to improve quit rates in combustible cigarette users. Including them in your quitting resolution may help you achieve your goal of stopping vaping.
Data from a recent Phase 3 trial showed that cytisinicline was 6-8x more effective than placebo in aiding people to quit smoking during a 6- or 12-week treatment period.
Participation in a clinical study helps provide information about the safety and effectiveness of investigational therapies.
What happens if I volunteer to participate in this study?
If you qualify and decide to participate in the study, you will be randomized into one of two groups:
- 12 weeks of cytisinicline
- 12 weeks of placebo
If you qualify and decide to participate in the study, you will receive the following:
- Study-related medical tests
- Financial stipend to help with travel costs and time