Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
X-22 Smoking Cessation Product · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| X-22 Smoking Cessation Product | EXPERIMENTAL | The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes. |
| Active Control Cigarette | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| X-22 Smoking Cessation Product | DRUG | 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. |
| Active Control Cigarettes | DRUG | 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. |
Inclusion Criteria: * Subjects must meet all of the following inclusion criteria to be eligible for participation in this study. 1. Subjects must be considered by the investigator to be in general good health and between 18 and 65 years of age, inclusive. 2. Subjects must have a history of smo...