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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...
X-22 Smoking Cessation Product is an investigational small molecule being developed for smoking cessation. It is a Phase 2 candidate from 22nd Century Group, Inc. The product is intended to help adults quit smoking and has been studied in a single completed randomized trial.
X-22 Smoking Cessation Product is being developed for smoking cessation in adults. It is intended as an aid to help people stop smoking. The clinical program enrolled adults aged 18 years and older, and the studied condition was smoking cessation.
X-22 Smoking Cessation Product is being developed by 22nd Century Group, Inc., which trades under the ticker XXII. The company is the sponsor of the clinical program for this smoking cessation candidate.
X-22 Smoking Cessation Product is in Phase 2 development. It is an investigational product and is not approved for marketing. The Phase 2 program consists of one completed trial, and no trials are currently active.
X-22 Smoking Cessation Product has been studied in one completed Phase 2 trial, NCT01400815, titled a randomized trial to evaluate the effectiveness of X-22 as a smoking cessation aid. The trial enrolled 234 participants in the United States and was randomized, double blind, and active controlled.