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ORCA-2: A Study of Cytisinicline for Smoking Cessation in Adult Smokers

Sponsor
Achieve Life Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT04576949
Collaborator
(none)
810
Enrollment
17
Locations
3
Arms
14.3
Actual Duration (Months)
47.6
Patients Per Site
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks as well as repeating that duration for a total of 84 days/12 weeks treatment.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
810 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
Actual Study Start Date :
Oct 13, 2020
Actual Primary Completion Date :
Dec 23, 2021
Actual Study Completion Date :
Dec 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo + Behavioral Support

one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks

Drug: Placebo
film-coated oral tablets containing matched placebo

Behavioral: Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
Experimental: Cytisinicline + Placebo + Behavioral Support

one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks

Drug: Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
Other Names:
  • Cytisine

    • Drug: Placebo
    film-coated oral tablets containing matched placebo

    Behavioral: Behavioral support
    Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
    Experimental: Cytisinicline + Behavioral Support

    one cytisinicline tablet PO TID plus behavioral support for 12 weeks

    Drug: Cytisinicline
    film-coated oral tablets containing 3 mg cytisinicline
    Other Names:
  • Cytisine

    • Behavioral: Behavioral support
    Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with smoking abstinence during the last 4 weeks of 6 weeks cytisinicline treatment versus placebo treatment (Wk 3-6) [Week 3-6]

      Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).

    2. Proportion of participants with smoking abstinence during the last 4 weeks of 12 weeks cytisinicline treatment versus placebo treatment (Wk 9-12) [Week 9-12]

      Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).

    Secondary Outcome Measures

    1. Proportion of participants with continuous smoking abstinence to Week 24 [Week 24]

      Smoking abstinence as verified by monthly expired CO measurements ≤10 ppm.

    2. Proportion of Participants Who are Relapse-Free at Week 24 [Week 24]

      Relapse is defined as participant reported resuming smoking or an expired CO measure ≥ 10ppm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female subjects, age ≥18 years.

    2. Current daily cigarette smokers (averaging at least 10 cigarettes per day upon completing a 7-day screening smoking diary) and who intend to quit smoking.

    3. Expired air carbon monoxide (CO) ≥10 ppm.

    4. Failed at least one previous attempt to stop smoking with or without therapeutic support.

    5. Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment.

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

    7. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.

    8. Sign the Informed Consent Form.

    Exclusion Criteria:

    1. More than 1 study participant in same household.

    2. Previous cytisinicline treatment in a prior clinical study or any other cytisine usage.

    3. Known hypersensitivity to cytisinicline or any of the excipients.

    4. Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline.

    5. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring).

    6. Clinically significant abnormalities in 12-lead ECG determined after minimum of 5 minutes in supine position within 28 days of randomization (ie, requiring treatment or further assessment).

    7. BMI classification for being underweight (<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2).

    8. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.

    9. Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).

    10. Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic.

    11. Currently having suicidal ideation or risk for suicide ("Yes" to question 4 or question 5 OR "Yes" to any suicidal behavior question on the C-SSRS).

    12. Current symptoms of moderate to severe depression (HADS score ≥11).

    13. Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min (estimated with the Cockroft-Gault equation).

    14. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN).

    15. Women who are pregnant or breast-feeding.

    16. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.

    17. Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.

    18. Treatment with other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to randomization or planned use of these other smoking cessation medications during the study.

    19. Use within the 2 weeks prior to randomization or planned use during the study of non-cigarette and/or noncombustible nicotine products (pipe tobacco, cigars, snuff, smokeless tobacco, hookah, e-cigarettes/vaping) or marijuana smoking or vaping.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alliance for Multispecialty Research, LLC. Mobile Alabama United States 36608
    2 Arizona State University Phoenix Arizona United States 85044
    3 Alliance for Multispecialty Research, LLC Coral Gables Florida United States 33134
    4 Clinical Research Atlanta Atlanta Georgia United States 30281
    5 MediSphere Medical Research Center, LLC Evansville Indiana United States 47714
    6 Alliance for Multispecialty Research, LLC Wichita Kansas United States 67207
    7 AMR Lexington Lexington Kentucky United States 40509
    8 Alliance for Multispecialty Research, LLC New Orleans Louisiana United States 70119
    9 Massachusetts General Hospital - Clinical Genetic Research Facility Boston Massachusetts United States 02114
    10 Alliance for Multispecialty Research, LLC Kansas City Missouri United States 64114
    11 Alliance for Multispecialty Research, LLC Las Vegas Nevada United States 89119
    12 Rochester Clinical Research, Inc. Rochester New York United States 14609
    13 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
    14 Coastal Carolina Research Center, Inc. Mount Pleasant South Carolina United States 29464
    15 Alliance for Multispecialty Research, LLC. Knoxville Tennessee United States 37920
    16 FutureSearch Trials of Dallas, LP Dallas Texas United States 75231
    17 Alliance for Multispecialty Research, LLC Norfolk Virginia United States 23502

    Sponsors and Collaborators

    • Achieve Life Sciences

    Investigators

    • Principal Investigator: Nancy Rigotti, MD, Mass General/Harvard Medical School

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Achieve Life Sciences
    ClinicalTrials.gov Identifier:
    NCT04576949
    Other Study ID Numbers:
    • ACH-CYT-03
    First Posted:
    Oct 6, 2020
    Last Update Posted:
    Jan 24, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 24, 2022