Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
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 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.