Cytisinicline for Smoking and Vaping Cessation

(ORCA-OL Trial)

Recruiting at 29 trial locations

Overseen By Nancy Rigotti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Achieve Life Sciences

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.

Research Team

Julie Ball

Principal Investigator

Achieve Life Sciences, Inc.

Eligibility Criteria

This trial is for adults who previously participated in ORCA-2/ORCA-3 or ORCA-V1 studies, currently smoke daily or use nicotine e-cigarettes. They must be willing to try quitting with behavioral support and have certain levels of CO or cotinine. Excluded are those with recent psychosis, severe depression, known cytisinicline sensitivity, abnormal blood tests/ECG results, liver issues, uncontrolled high blood pressure, recent serious heart problems, severe kidney issues, pregnant/breastfeeding women or women not using birth control.

Inclusion Criteria

I smoke cigarettes or use nicotine e-cigarettes daily.

Willing to actively participate in the study's cessation behavioral support provided throughout the study

At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes

Exclusion Criteria

Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study

Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide; or current symptoms of moderate to severe depression at screening

Known hypersensitivity to cytisinicline or any of the excipients

Treatment Details

Interventions

• Cytisinicline (Nicotinic Acetylcholine Receptor Agonist)

Trial Overview The study is testing the safety of a smoking cessation aid called Cytisinicline taken three times daily for one year. Participants will receive behavioral support to quit smoking/vaping and start treatment the day after enrolling with a set quit date within two weeks.

Participant Groups

Group I: Cytisinicline 3 mg TID Experimental Treatment 1 Intervention

Cytisinicline 3 mg TID for 52 weeks.

Cytisinicline is already approved in Canada for the following indications:

Approved in Canada as Cravv for:

• Smoking cessation

Who Is Running the Clinical Trial?

Achieve Life Sciences

Lead Sponsor

Trials

36

Recruited

7,800+