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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04576949
Recruitment Status : Active, not recruiting
First Posted : October 6, 2020
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

Tracking Information
First Submitted Date  ICMJE September 25, 2020
First Posted Date  ICMJE October 6, 2020
Last Update Posted Date July 6, 2021
Actual Study Start Date  ICMJE October 13, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Proportion of participants with smoking abstinence during the last 4 weeks of 6 weeks cytisinicline treatment versus placebo treatment (Wk 3-6) [ Time Frame: Week 3-6 ]
    Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).
  • Proportion of participants with smoking abstinence during the last 4 weeks of 12 weeks cytisinicline treatment versus placebo treatment (Wk 9-12) [ Time Frame: Week 9-12 ]
    Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • Proportion of participants with continuous smoking abstinence to Week 24 [ Time Frame: Week 24 ]
    Smoking abstinence as verified by monthly expired CO measurements ≤10 ppm.
  • Proportion of Participants Who are Relapse-Free at Week 24 [ Time Frame: Week 24 ]
    Relapse is defined as participant reported resuming smoking or an expired CO measure ≥ 10ppm
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Cytisinicline for Smoking Cessation in Adult Smokers
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Cytisinicline
    film-coated oral tablets containing 3 mg cytisinicline
    Other Name: 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo + Behavioral Support
    one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
    Interventions:
    • Drug: Placebo
    • Behavioral: Behavioral support
  • 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
    Interventions:
    • Drug: Cytisinicline
    • Drug: Placebo
    • Behavioral: Behavioral support
  • Experimental: Cytisinicline + Behavioral Support
    one cytisinicline tablet PO TID plus behavioral support for 12 weeks
    Interventions:
    • Drug: Cytisinicline
    • Behavioral: Behavioral support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 2, 2021)
792
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
750
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04576949
Other Study ID Numbers  ICMJE ACH-CYT-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Achieve Life Sciences
Study Sponsor  ICMJE Achieve Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nancy Rigotti, MD Mass General/Harvard Medical School
PRS Account Achieve Life Sciences
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP