Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Global Action to End Smoking | UNKNOWN |
Not provided
Not provided
Not provided
To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Non-Responders | Experimental | Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study. |
|
| Nicotine Responders - Group 1 | Experimental | Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period). |
|
| Nicotine Responders - Group 2 | Experimental | Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicoderm | Drug | Depending on responder status and group assignment the maximum amount of time nicotine patches will be used is 24 weeks. The final four weeks of nicotine patch treatment will comprise 2 weeks of 14 mg patches and two weeks of 7 mg patches. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking abstinence - CO | To determine whether maintained use of nicotine products can help sustain smoking abstinence rates for early responders. An expired air CO reading of ≤ 5 ppm at 24 weeks. | Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking abstinence - Self report of no smoking | Percent smoking abstinence at 12 weeks and 24 weeks, defined on an intent-to-treat basis as a self-report of no-smoking for the prior 7 days | Week 12 and Week 24 |
| Reduction in Expired Air CO |
Not provided
Inclusion Criteria:
Exclusion Criteria:
If female, participant is pregnant, nursing, or intends to become pregnant during the time period from screening through the end of study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rose Research Center | Charlotte | North Carolina | 28262 | United States | ||
| Rose Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Nicorette 4Mg Chewing Gum | Drug | 4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 24 weeks. |
|
|
| Nicorette Lozenge Product | Drug | 4mg Nicorette mint lozenge; as needed maximum usage 24 weeks. |
|
|
| NJOY e-cigarette | Other | Each NJOY Classic Tobacco and Menthol pod is pre-filled with 1.9 mL of e-liquid with 5% nicotine (by weight); as needed maximum usage 24 weeks. |
|
| on! | Other | 4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 24 weeks. |
|
|
Percent of participants achieving a 50% reduction in expired air CO at 12 weeks and 24 weeks relative to baseline.
| Week 12 and Week 24 |
| Usage of Nicotine Products | Self-reported usage of nicotine products. | Week 1 through Week 24, Week 36 |
| Saliva Cotinine Concentrations | Saliva cotinine concentrations reflective of nicotine product usage in smoking-abstinent individuals. | Week 12, Week 24, Week 36 |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D009538 | Nicotine |
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013812 | Therapeutics |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided