Phase 2
Completed N=254
Trial of Cytisine in Adult Smokers
Source: ClinicalTrials.gov NCT03709823 ↗Enrolled (actual)
254
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment — 26.62; 25.04; 47.10; 29.40 percentage of cigarettes smoked — p=0.0002
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Analysis of Primary Outcome Measure: Percentage of Expected Cigarettes Smoked Per Participant During Study Treatment |
26.62; 25.04; 47.10; 29.40; 32.50; 35.30 | 0.0002 sig |
| PRIMARY Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, Commercial Schedule |
26.68; 25.08; 41.29 | 0.0010 sig |
| PRIMARY Sensitivity Analysis of Primary Outcome Measure: Analysis for Percentage of Expected Cigarettes Smoked Versus Pooled Placebo Arms, TID Schedule |
29.29; 32.41; 41.71 | 0.0091 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, age ≥ 18 years.
- Current daily cigarette smokers (averaging ≥ 10 cigarettes per day upon completing a 7-day screening diary) and who intend to quit smoking.
- Expired air carbon monoxide (CO) ≥ 10 parts per million (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 that is 5-7 days after starting treatment.
- Willing to actively participate in the study's smoking cessation behavioral support provided throughout the study.
- Able to fully understand all study requirements, willing to participate, comply with dosing schedule, and sign the Informed Consent Form.
Exclusion Criteria
- Known hypersensitivity to cytisine or any of the excipients.
- Positive urinary drugs of abuse screen, determined within 28 days before the first dose of cytisine.
- Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e. requiring treatment).
- 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).
- Body mass index (BMI) classification for being underweight ( 2.0 times the upper limit of normal (ULN).
- Women who are pregnant or breast-feeding.
- Male or Female subjects of child bearing 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 within 4 weeks of randomization.
- 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.
- 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.
- Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Data sourced from ClinicalTrials.gov (NCT03709823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.