Conditions: Smoking Cessation
Keywords: smoking smoking cessation quitting smoking
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 234
Healthy volunteers: no

Brief 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 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.

Detailed description:

Arms:
arm 1: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. arm 2: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.

Interventions: intervention 1: X-22 Smoking Cessation Product intervention 2: Active Control Cigarettes
Intervention descriptions: intervention 1: The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.

Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period. intervention 2: The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.

Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.

Protocol document: