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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 : April 30, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Cytisine Drug: Placebo Comparator Behavioral: Behavioral support Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 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 2b Trial of Cytisine in Adult Smokers
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : April 23, 2019
Actual Study Completion Date : April 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1.5 mg Cytisine, Commercial Schedule
1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
Drug: Cytisine
film coated tablet containing 1.5 mg cytisine in a single tablet

Behavioral: Behavioral support
12 behavioral support sessions by a qualified staff member plus supportive literature and online resources

Experimental: 3.0 mg Cytisine, Commercial Schedule
3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
Drug: Cytisine
film coated tablet containing 1.5 mg cytisine in a single tablet

Behavioral: Behavioral support
12 behavioral support sessions by a qualified staff member plus supportive literature and online resources

Placebo Comparator: Placebo, Commercial Schedule
Placebo tablets using the commercial 25-day titration schedule + behavioral support
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

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
Drug: Cytisine
film coated tablet containing 1.5 mg cytisine in a single tablet

Behavioral: Behavioral support
12 behavioral support sessions by a qualified staff member plus supportive literature and online resources

Experimental: 3.0 mg Cytisine, TID Schedule
3.0 mg cytisine dose for 25 days using a simplified TID schedule + behavioral support
Drug: Cytisine
film coated tablet containing 1.5 mg cytisine in a single tablet

Behavioral: Behavioral support
12 behavioral support sessions by a qualified staff member plus supportive literature and online resources

Placebo Comparator: Placebo, TID Schedule
Placebo tablets for 25 days using a simplified TID schedule + behavioral support
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




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).



Information from the National Library of Medicine

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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 ≥ 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.

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): NCT03709823


Locations
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United States, Arizona
Clinical Research Consortium
Tempe, Arizona, United States, 85283
United States, California
Los Angeles Clinical Trials
Burbank, California, United States, 91505
United States, Kentucky
Central Kentucky Research Associates, LLC
Lexington, Kentucky, United States, 40509
United States, Missouri
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States, 64114
United States, New York
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
United States, South Carolina
Coastal Carolina Research Center, Inc
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Volunteer Research Group
Knoxville, Tennessee, United States, 37920
United States, Texas
FutureSearch Trails of Dallas, LP
Dallas, Texas, United States, 57231
Sponsors and Collaborators
Achieve Life Sciences
Investigators
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Principal Investigator: Mitchell Nides, PhD Los Angeles Clinical Trials
  Study Documents (Full-Text)

Documents provided by Achieve Life Sciences:
Study Protocol  [PDF] April 15, 2019
Statistical Analysis Plan  [PDF] May 29, 2019

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Responsible Party: Achieve Life Sciences
ClinicalTrials.gov Identifier: NCT03709823    
Other Study ID Numbers: ACH-CYT-09
First Posted: October 17, 2018    Key Record Dates
Results First Posted: April 30, 2020
Last Update Posted: May 18, 2020
Last Verified: May 2020
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