Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Nicotine gum (C)
Nicotine gum · 2 trials · 1 indication
The maximum reduction in Visual Analog Scale (VAS) score for the question "Urges to smoke" (Tobacco/Nicotine Withdrawal Questionnaire) between pre-use and post-use (i.e., VASpre-use1 - VASpost-use1) during the first product use in Part B.
The largest VAS score recorded for the response to the question "Is the product "Pleasant" right now?" (Direct Effects of Product Questionnaire) during the first product use in Part B.
| Arm | Type | Description |
|---|---|---|
| VLN Menthol Cigarettes (A) | EXPERIMENTAL | Subjects will smoke VLN menthol cigarettes |
| Usual Brand Menthol Cigarettes (B) | EXPERIMENTAL | Subjects will smoke their usual brand menthol cigarettes |
| Nicotine Gum (C) | EXPERIMENTAL | Subjects will chew nicotine gum |
| VLN Cigarettes (A) | EXPERIMENTAL | Subjects will smoke VLN cigarettes |
| Usual Brand Cigarettes (B) | EXPERIMENTAL | Subjects will smoke their usual brand cigarettes |
| Name | Type | Description |
|---|---|---|
| VLN menthol cigarettes (A) | OTHER | 0.4mg nicotine / g tobacco king size filter menthol cigarette |
| Usual Brand Menthol Cigarettes (B) | OTHER | Usual brand king size menthol cigarettes |
| Nicotine gum (C) | DRUG | 4 mg nicotine gum |
| VLN cigarettes (A) | OTHER | 0.4mg nicotine / g tobacco king size filter cigarette |
| Usual Brand Cigarettes (B) | OTHER | Usual brand king size non-menthol cigarettes |
Inclusion Criteria: Subjects will be required to meet each one of the following inclusion criteria in order to be eligible for participation in the study: 1. Must provide written informed consent prior to the initiation of any protocol-specific procedures. 2. Male and female adults, between 22 to ...
Nicotine gum is being studied for tobacco use, the dependence on nicotine that drives smoking. It delivers nicotine as a small molecule and is being developed by 22nd Century Group, Inc. under the ticker XXII. The program is in Phase 1 clinical development, so it is investigational and not an approved product.
Nicotine gum targets the nicotinic acetylcholine receptors CHRNB2 and CHRNA4, acting as an agonist at those receptors. By binding and activating these receptor subtypes, it mimics the effect of nicotine delivered through tobacco. This receptor activity is the basis for its investigation in tobacco use.
Nicotine gum is being developed by 22nd Century Group, Inc., which trades under the ticker XXII. The company is the sponsor behind the clinical program evaluating the product in tobacco use. Development remains at the Phase 1 stage.
Nicotine gum is in Phase 1 clinical development. It is investigational and has not been approved for marketing. Two Phase 1 trials have been completed, and no trials are currently active. The program is sponsored by 22nd Century Group, Inc. under the ticker XXII.
Two completed Phase 1 trials have evaluated nicotine gum. NCT03559751 studied abuse liability of very low nicotine cigarettes in 66 participants, and NCT03559725 studied abuse liability of very low nicotine mentholated cigarettes in 55 participants. Both were conducted in the United States in adults aged 22 years and older, including healthy volunteers.
Yes, nicotine gum (C) is another name for nicotine gum. Both refer to the same investigational product being developed by 22nd Century Group, Inc. under the ticker XXII for tobacco use. Searches using either name point to the same Phase 1 program.