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Clinical Trials/NCT04576949
NCT04576949CompletedPhase 3

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers

Achieve Life Sciences17 sites in 1 country810 target enrollmentStarted: October 13, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
810
Locations
17
Primary Endpoint
Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6

Study Overview

Brief Summary

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male or female subjects, age ≥18 years.
  • 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.
  • Expired air carbon monoxide (CO) ≥10 ppm.
  • Failed at least one previous attempt to stop smoking with or without therapeutic support.
  • Willing to initiate study treatment on the day after randomization and set a quit date within 5-7 days of starting treatment.
  • Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
  • Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
  • Sign the Informed Consent Form.

Exclusion Criteria

  • More than 1 study participant in same household.
  • Previous cytisinicline treatment in a prior clinical study or any other cytisine usage.
  • Known hypersensitivity to cytisinicline or any of the excipients.
  • Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisinicline.
  • Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (ie, requiring treatment or monitoring).
  • Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (ie, requiring treatment or further assessment).
  • Body mass index (BMI) classification for being underweight (<18.5 kg/m^2) or having ≥Class 2 obesity (≥35 kg/m^2).
  • Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
  • Current uncontrolled hypertension (blood pressure ≥160/100 mmHg).
  • Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic.
  • Currently having suicidal ideation or risk for suicide ("Yes" to question 4 or question 5 OR "Yes" to any suicidal behavior question on the Columbia - Suicide Severity Rating Scale [C-SSRS]).
  • Current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale[HADS] score ≥11).
  • Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min (estimated with the Cockroft-Gault equation).
  • Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN).
  • Women who are pregnant or breast-feeding.
  • Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
  • Participation in a clinical study with an investigational drug in the 4 weeks prior to randomization.
  • 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.
  • 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.
  • Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Arms & Interventions

Placebo + Behavioral Support

Placebo Comparator

one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks

Intervention: Placebo (Drug)

Placebo + Behavioral Support

Placebo Comparator

one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks

Intervention: Behavioral support (Behavioral)

Cytisinicline + Placebo + Behavioral Support

Experimental

one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks

Intervention: Cytisinicline (Drug)

Cytisinicline + Placebo + Behavioral Support

Experimental

one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks

Intervention: Placebo (Drug)

Cytisinicline + Placebo + Behavioral Support

Experimental

one cytisinicline tablet PO TID plus behavioral support for 6 weeks followed by one placebo tablet PO TID plus behavioral support for 6 weeks

Intervention: Behavioral support (Behavioral)

Cytisinicline + Behavioral Support

Experimental

one cytisinicline tablet PO TID plus behavioral support for 12 weeks

Intervention: Cytisinicline (Drug)

Cytisinicline + Behavioral Support

Experimental

one cytisinicline tablet PO TID plus behavioral support for 12 weeks

Intervention: Behavioral support (Behavioral)

Outcomes

Primary Outcomes

Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6

Time Frame: Weeks 3 to 6

Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤10 parts per million (ppm).

Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12

Time Frame: Weeks 9 to 12

Smoking abstinence as verified by weekly expired CO measurements ≤10 ppm.

Secondary Outcomes

  • Percentage of Participants With Continuous Smoking Abstinence From Week 6 to Week 24(Week 6 to Week 24)
  • Percentage of Participants With Continuous Smoking Abstinence From Week 12 to Week 24(Week 12 to Week 24)
  • Percentage of Participants Taking Cytisinicline Who Were Relapse-Free at Week 24(Week 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (17)

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