A Study of Cytisinicline for Smoking Cessation in Adult Smokers (ORCA-2 Trial)
Palo Alto (17 mi)Overseen byNancy Rigotti, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Achieve Life Sciences
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a drug called cytisinicline, taken three times a day, to help people quit smoking. The study lasts for several weeks or a few months. Cytisinicline works by reducing cravings and withdrawal symptoms, making it easier to stop smoking. Cytisinicline, also known as cytisine, has been used as a smoking cessation aid in Central and Eastern Europe since the 1960s.
Eligibility Criteria
Treatment Details
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Cytisinicline + Placebo + Behavioral SupportExperimental Treatment3 Interventions
one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks
Group II: Cytisinicline + Behavioral SupportExperimental Treatment2 Interventions
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
Group III: Placebo + Behavioral SupportPlacebo Group2 Interventions
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
Cytisinicline is already approved in Canada, United Kingdom for the following indications:
🇨🇦 Approved in Canada as Cravv for:
- Smoking cessation
🇬🇧 Approved in United Kingdom as Cytisine for:
- Smoking cessation
Find a clinic near you
Research locations nearbySelect from list below to view details:
Massachusetts General Hospital - Clinical Genetic Research FacilityBoston, MA
MediSphere Medical Research Center, LLCEvansville, IN
Clinical Research AtlantaAtlanta, GA
Alliance for Multispecialty Research, LLCWichita, KS
More Trial Locations
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Who is running the clinical trial?
Achieve Life SciencesLead Sponsor