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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04576949
Other study ID # ACH-CYT-03
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 13, 2020
Est. completion date December 23, 2021

Study information

Verified date December 2022
Source Achieve Life Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Achieve Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

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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