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Trial of Cytisine in Adult Smokers

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: NCT03709823
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 17, 2018
Results First Submitted Date  ICMJE April 16, 2020
Results First Posted Date  ICMJE May 18, 2020
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE November 13, 2018
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2020)
  • Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment [ Time Frame: Day 1 through Day 25 ]
    The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. The percentage of expected cigarettes smoked was computed as Y = (100 x N) / (T x R) where N represents total number of cigarettes smoked each day over the treatment period from Day 1 to Day 25; T represents number of post-randomization days where number of cigarettes smoked is recorded; and R represents the average number of cigarettes smoked daily over the 7-day screening period as baseline. T*R represents the total number of cigarettes that would have been smoked without intervention over the number of recorded days. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
  • Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule [ Time Frame: Day 1 through Day 25 ]
    The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
  • Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule [ Time Frame: Day 1 through Day 25 ]
    The daily cigarette counts (number of cigarettes smoked in the past 24 hours) were self-reported by participants in the diary. Percentage of expected cigarettes smoked was computed for each participant at the end of treatment (cigarette score), based on daily cigarette counts during treatment vs the screening period. (See Outcome Measure 1 description for details.) The sensitivity analysis of the primary outcome measure was only performed if results of "Statistical Analysis 5" for Outcome Measure 1 demonstrated the placebo treatment arms (commercial and TID) were not significantly different, and so could be pooled. Separate statistical analyses were performed for the two cytisine administration schedules (commercial and TID).
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment [ Time Frame: Day 1 through Day 25 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2018)
Number of Participants With Smoking Abstinence Starting at Week 4 and Documented at Weeks 5, 6, 7 and 8 Post-Randomization [ Time Frame: Week 4 through Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Cytisine in Adult Smokers
Official Title  ICMJE A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisine in Adult Smokers
Brief Summary This placebo-controlled Phase 2b trial is being conducted at sites within the United States (US) to evaluate the effectiveness cytisine dosage (1.5 mg, 3.0 mg) and administration schedule (commercial titration versus simplified 3 times daily [TID] schedule) within a 25-day treatment period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Cytisine
    film coated tablet containing 1.5 mg cytisine in a single tablet
  • Drug: Placebo Comparator
    1.5 mg cellulose powder to match final weight of the cytisine tablet
  • Behavioral: Behavioral support
    12 behavioral support sessions by a qualified staff member plus supportive literature and online resources
Study Arms  ICMJE
  • Experimental: 1.5 mg Cytisine, Commercial Schedule
    1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Experimental: 3.0 mg Cytisine, Commercial Schedule
    3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Placebo Comparator: Placebo, Commercial Schedule
    Placebo tablets using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Placebo Comparator
    • Behavioral: Behavioral support
  • Experimental: 1.5 mg Cytisine, TID Schedule
    1.5 mg cytisine dose for 25 days using a simplified 3 times daily (TID) schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Experimental: 3.0 mg Cytisine, TID Schedule
    3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Placebo Comparator: Placebo, TID Schedule
    Placebo tablets for 25 days using a simplified TID schedule + behavioral support
    Interventions:
    • Drug: Placebo Comparator
    • Behavioral: Behavioral support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
254
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
250
Actual Study Completion Date  ICMJE April 23, 2019
Actual Primary Completion Date April 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects, age ≥ 18 years.
  2. Current daily cigarette smokers (averaging ≥ 10 cigarettes per day upon completing a 7-day screening diary) and who intend to quit smoking.
  3. Expired air carbon monoxide (CO) ≥ 10 parts per million (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 that is 5-7 days after 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, comply with dosing schedule, and sign the Informed Consent Form.

Exclusion Criteria:

  1. Known hypersensitivity to cytisine or any of the excipients.
  2. Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisine.
  3. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e. requiring treatment).
  4. Clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e. requiring treatment or further assessment).
  5. Body mass index (BMI) classification for being underweight (< 18.5 kg/m^2) or having ≥ Class 2 obesity (≥ 35 kg/m^2).
  6. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
  7. Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg).
  8. Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic; having suicidal ideation (Suicide Behaviors Questionnaire-Revised [SBQ-R] score ≥ 7); or current symptoms of moderate to severe depression (Hospital Anxiety and Depression Scale [HADS] score ≥ 11).
  9. Renal impairment defined as a creatinine clearance (CrCl) < 60 mL/min (estimated with the Cockroft-Gault equation) or hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN).
  10. Women who are pregnant or breast-feeding.
  11. Male or Female subjects of child bearing potential who do not agree to use acceptable methods of birth control during the study treatment period.
  12. Participation in a clinical study with an investigational drug within 4 weeks of randomization.
  13. Treatment with other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) within 4 weeks of randomization or planned use of these other smoking cessation medications during the study.
  14. Use within 2 weeks of randomization or planned use during the study of non-cigarette nicotine products (e-cigarettes, pipe tobacco, cigars, snuff, chewing tobacco, hookah) or marijuana vaping or smoking.
  15. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03709823
Other Study ID Numbers  ICMJE ACH-CYT-09
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Achieve Life Sciences
Study Sponsor  ICMJE Achieve Life Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mitchell Nides, PhD Los Angeles Clinical Trials
PRS Account Achieve Life Sciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP