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Alkaloid

Cytisinicline for Smoking Cessation (ORCA-2 Trial)

Phase 3
Waitlist Available
Led By Nancy Rigotti, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 to week 24
Awards & highlights
Pivotal Trial

Summary

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6
Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12
Secondary study objectives
Percentage of Participants Taking Cytisinicline Who Were Relapse-Free at Week 24
Percentage of Participants With Continuous Smoking Abstinence From Week 12 to Week 24
Percentage of Participants With Continuous Smoking Abstinence From Week 6 to Week 24

Side effects data

From 2021 Phase 3 trial • 810 Patients • NCT04576949
10%
Insomnia
8%
Abnormal dreams
8%
Headache
6%
Nausea
6%
Anxiety
5%
Constipation
4%
Diarrhoea
3%
Fatigue
3%
COVID-19
3%
Urinary tract infection
3%
Weight increased
3%
Back pain
3%
Irritability
2%
Dry mouth
2%
Vomiting
2%
Dizziness
2%
Hypertension
1%
Sinusitis
1%
Depression
1%
Sleep disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Behavioral Support
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
12 Week Cytisinicline + Behavioral Support

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral support
2022
Completed Phase 4
~2290
Placebo
1995
Completed Phase 3
~2670
Cytisinicline
2022
Completed Phase 3
~1660

Find a Location

Who is running the clinical trial?

Achieve Life SciencesLead Sponsor
35 Previous Clinical Trials
6,958 Total Patients Enrolled
Nancy Rigotti, MDPrincipal InvestigatorMass General/Harvard Medical School
1 Previous Clinical Trials
234 Total Patients Enrolled
~159 spots leftby Nov 2025
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