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

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: NCT05206370
Recruitment Status : Completed
First Posted : January 25, 2022
Last Update Posted : April 4, 2023
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

Study Description
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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
Smoking Cessation Drug: Cytisinicline Drug: Placebo Behavioral: Behavioral support Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 792 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Second Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
Actual Study Start Date : January 20, 2022
Actual Primary Completion Date : March 21, 2023
Actual Study Completion Date : March 21, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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.
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 Name: 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
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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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Week 24 ]
    Smoking abstinence as verified by monthly expired CO measurements ≤ 10 ppm.

  2. 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 ≥ 10 ppm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 all 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 during the 12-week treatment period.
  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. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, or hospitalization for congestive heart failure.
  8. Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
  9. Currently psychotic or having had a psychotic event within 3 months. If any subject becomes psychotic during the study, they must be removed from treatment and/or additional study visits.
  10. Currently having suicidal ideation or risk for suicide ("Yes" to either question 4 or question 5 OR "Yes" to any suicidal behavior question on the C-SSRS with clear suicidal intent or previous attempt).
  11. Current symptoms of moderate to severe depression (depression score ≥11on the HADS).
  12. Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min (estimated with the Cockroft-Gault equation).
  13. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN).
  14. Women who are pregnant or breast-feeding.
  15. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
  16. Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
  17. 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.
  18. 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.
  19. 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05206370


Locations
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United States, Florida
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States, 32720
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States, 33912
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
United States, Illinois
Affinity Health Corp
Oak Brook, Illinois, United States, 60523
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, New Jersey
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, United States, 08540
United States, North Carolina
Trial Management Associates, LLC
Wilmington, North Carolina, United States, 28403
United States, Ohio
Velocity Clinical Research, Inc.
Cleveland, Ohio, United States, 44122
Aventiv Research Inc
Columbus, Ohio, United States, 43212
United States, Oklahoma
Intend Research
Norman, Oklahoma, United States, 73069
United States, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Virginia
Health Research of Hampton Toads, Inc
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Achieve Life Sciences
Investigators
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Study Director: Daniel Cain, Vice-President Clinical Research Achieve Life Sciences, Inc.
More Information
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Responsible Party: Achieve Life Sciences
ClinicalTrials.gov Identifier: NCT05206370    
Other Study ID Numbers: ACH-CYT-04
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No