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A Prospective, Double-blind, Randomized, Active Controlled, Parallel Group, Multicenter Phase II Clinical Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
A randomized, active controlled clinical trial in which a total of 216 healthy smokers will be enrolled and followed over approximately 19 weeks. The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid. Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be randomized in a 1:1 ratio to 1 of the 2 treatment arms: * Group 1: X-22 Cigarettes (very low nicotine) * Group 2: Active Control Cigarettes The randomization will be stratified by gender. Efficacy will be assessed by analysis of cigarette consumption using self-report diaries and measurement of exhaled carbon monoxide (CO) and cotinine concentrations. Safety will be assessed by evaluation of adverse events, physical examinations, clinical laboratory tests, and measurement of heart rate, blood pressure, and body weight at each study visit.
Details
| Lead sponsor | 22nd Century Limited, LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 234 |
| Start date | 2011-07 |
| Completion | 2012-12 |
Conditions
- Smoking Cessation
Interventions
- X-22 Smoking Cessation Product
- Active Control Cigarettes
Primary outcomes
- Efficacy - 4 Weeks of Continuous Abstinence From Smoking Cigarettes — Weeks 7 and 9 = telephone call, Week 8 = visit 6 and Week 10 = visit 7
The primary efficacy measurement is the number of subjects with 4 weeks of continuous abstinence from smoking cigarettes (Weeks 7-10), as assessed by subject diary and confirmed by exhaled carbon monoxide (CO), after treatment termination, at Visits 6 and 7. A responder: did not smoke and had less than 10 ppm exhaled CO.
Countries
United States