Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03559725 | Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes | PHASE1 | COMPLETED | 55 | — | — | May 1, 2018 | Oct 4, 2018 | Mar 25, 2020 | 1 | United States |
| NCT03559751 | Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes | PHASE1 | COMPLETED | 66 | — | — | Apr 13, 2018 | Sep 6, 2018 | Mar 26, 2020 | 1 | United States |
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 ...