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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

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

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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 Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
Actual Study Start Date : October 13, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.




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 ≥ 10ppm



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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 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.

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): NCT04576949


Locations
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United States, Alabama
Alliance for Multispecialty Research, LLC.
Mobile, Alabama, United States, 36608
United States, Arizona
Arizona State University
Phoenix, Arizona, United States, 85044
United States, Florida
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States, 33134
United States, Georgia
Clinical Research Atlanta
Atlanta, Georgia, United States, 30281
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Kansas
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
AMR Lexington
Lexington, Kentucky, United States, 40509
United States, Louisiana
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States, 70119
United States, Massachusetts
Massachusetts General Hospital - Clinical Genetic Research Facility
Boston, Massachusetts, United States, 02114
United States, Missouri
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States, 64114
United States, Nevada
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States, 89119
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, North Carolina
M3 Wake Research, Inc.
Raleigh, North Carolina, United States, 27612
United States, South Carolina
Coastal Carolina Research Center, Inc.
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Alliance for Multispecialty Research, LLC.
Knoxville, Tennessee, United States, 37920
United States, Texas
FutureSearch Trials of Dallas, LP
Dallas, Texas, United States, 75231
United States, Virginia
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Achieve Life Sciences
Investigators
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Principal Investigator: Nancy Rigotti, MD Mass General/Harvard Medical School
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Responsible Party: Achieve Life Sciences
ClinicalTrials.gov Identifier: NCT04576949    
Other Study ID Numbers: ACH-CYT-03
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
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