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Alkaloid

A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers (ORCA-3 Trial)

Phase 3
Waitlist Available
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 9-12
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 9-12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9-12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants With Smoking Abstinence During the Last 4 Weeks of 12 Weeks Cytisinicline Treatment Versus Placebo Treatment (Wk 9-12)
Proportion of Participants With Smoking Abstinence During the Last 4 Weeks of 6 Weeks Cytisinicline Treatment Versus Placebo Treatment (Wk 3-6)
Secondary study objectives
Proportion of Participants Who are Relapse-Free at Week 24
Proportion of Participants With Continuous Smoking Abstinence to Week 24

Side effects data

From 2021 Phase 3 trial • 810 Patients • NCT04576949
10%
Insomnia
8%
Headache
8%
Abnormal dreams
6%
Anxiety
6%
Nausea
5%
Constipation
4%
Diarrhoea
3%
Back pain
3%
Fatigue
3%
COVID-19
3%
Weight increased
3%
Irritability
3%
Urinary tract infection
2%
Dizziness
2%
Hypertension
2%
Dry mouth
2%
Vomiting
1%
Depression
1%
Sinusitis
1%
Sleep disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
6 Week Cytisinicline + 6 Week Placebo + Behavioral Support
12 Week Cytisinicline + Behavioral Support
Placebo + 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
Cytisine
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670
Behavioral support
2022
Completed Phase 4
~2290

Find a Location

Who is running the clinical trial?

Achieve Life SciencesLead Sponsor
35 Previous Clinical Trials
6,976 Total Patients Enrolled
Daniel Cain, Vice-President Clinical ResearchStudy DirectorAchieve Life Sciences, Inc.
1 Previous Clinical Trials
160 Total Patients Enrolled
~202 spots leftby Dec 2025
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