Smoking Cessation Clinical Trial
— ORCA-2Official title:
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
Verified date | December 2022 |
Source | Achieve Life Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 810 |
Est. completion date | December 23, 2021 |
Est. primary completion date | December 23, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Research Atlanta | Atlanta | Georgia |
United States | Massachusetts General Hospital - Clinical Genetic Research Facility | Boston | Massachusetts |
United States | Alliance for Multispecialty Research, LLC | Coral Gables | Florida |
United States | FutureSearch Trials of Dallas, LP | Dallas | Texas |
United States | MediSphere Medical Research Center, LLC | Evansville | Indiana |
United States | Alliance for Multispecialty Research, LLC | Kansas City | Missouri |
United States | Alliance for Multispecialty Research, LLC. | Knoxville | Tennessee |
United States | Alliance for Multispecialty Research, LLC | Las Vegas | Nevada |
United States | AMR Lexington | Lexington | Kentucky |
United States | Alliance for Multispecialty Research, LLC. | Mobile | Alabama |
United States | Coastal Carolina Research Center, Inc. | Mount Pleasant | South Carolina |
United States | Alliance for Multispecialty Research, LLC | New Orleans | Louisiana |
United States | Alliance for Multispecialty Research, LLC | Norfolk | Virginia |
United States | Arizona State University | Phoenix | Arizona |
United States | M3 Wake Research, Inc. | Raleigh | North Carolina |
United States | Rochester Clinical Research, Inc. | Rochester | New York |
United States | Alliance for Multispecialty Research, LLC | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Achieve Life Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with smoking abstinence during the last 4 weeks of 6 weeks cytisinicline treatment versus placebo treatment (Wk 3-6) | Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements =10 parts per million (ppm). | Week 3-6 | |
Primary | Proportion of participants with smoking abstinence during the last 4 weeks of 12 weeks cytisinicline treatment versus placebo treatment (Wk 9-12) | Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements =10 parts per million (ppm). | Week 9-12 | |
Secondary | Proportion of participants with continuous smoking abstinence to Week 24 | Smoking abstinence as verified by monthly expired CO measurements =10 ppm. | Week 24 | |
Secondary | Proportion of Participants Who are Relapse-Free at Week 24 | Relapse is defined as participant reported resuming smoking or an expired CO measure = 10ppm | Week 24 |
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