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Trial record 2 of 38 for:    Achieve Life Sciences

Trial of Cytisine in Adult Smokers

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ClinicalTrials.gov Identifier: NCT03709823
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : March 5, 2019
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
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE November 13, 2018
Estimated Primary Completion Date May 12, 2019   (Final data collection date for primary outcome measure)
Current 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03709823 on ClinicalTrials.gov Archive Site
Current 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
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 Phase 2b trial is being conducted at sites within the United States (US) to evaluate cytisine dosage and administration schedules 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: Arm A: 1.5 mg Cytisine, Titration
    1.5 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Experimental: Arm B: 3.0 mg Cytisine, Titration
    3.0 mg cytisine dose using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Placebo Comparator: Arm C: Placebo, Titration
    Placebo tablets using the commercial 25-day titration schedule + behavioral support
    Interventions:
    • Drug: Placebo Comparator
    • Behavioral: Behavioral support
  • Experimental: Arm D: 1.5 mg Cytisine, TID
    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: Arm E: 3.0 mg Cytisine, TID
    3.0 mg cytisine dose for 25 days using a simplified tid schedule + behavioral support
    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioral support
  • Placebo Comparator: Arm F: Placebo, TID
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 4, 2019)
254
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2018)
250
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date May 12, 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 at least 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 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 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: Undecided
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 March 2019

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