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Nicotinic Acetylcholine Receptor Agonist

Cytisinicline for Smoking and Vaping Cessation (ORCA-OL Trial)

Phase 3
Recruiting
Research Sponsored by Achieve Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN) on screening lab
Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial aims to study the safety of taking 3 mg of cytisinicline three times a day for 52 weeks in the United States."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include nausea, headaches, trouble sleeping and increased appetite which could lead to weight gain. Side effects can vary based on individual health conditions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver tests are higher than normal.
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I haven't had a heart attack, stroke, or heart failure hospitalization in the last 3 months.
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My kidney function is severely impaired.
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I am not pregnant or breast-feeding.
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I am a woman able to have children and agree to use birth control during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cytisinicline 3 mg TIDExperimental Treatment1 Intervention
Cytisinicline 3 mg TID for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytisinicline
2022
Completed Phase 3
~1660

Find a Location

Who is running the clinical trial?

Achieve Life SciencesLead Sponsor
35 Previous Clinical Trials
7,118 Total Patients Enrolled
Julie BallStudy DirectorAchieve Life Sciences, Inc.
~433 spots leftby Dec 2025
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