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Lack of participant/departmental interest. Nearing end of pilot grant award.
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The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement Therapy (NRT) | Active Comparator | Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information. |
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| Control Non NRT Therapy | Other | Subject will be provided with a box/bag containing a WV QL fact sheet/contact information. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Therapy Agent | Combination Product | The NRT Agents-- 21mg nicotine patches (x14) and 2 mg nicotine lozenges (~210). |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Continued Abstinence Rate (2 weeks) | Percentage of subjects who self-report continued abstinence in tobacco use at 2 weeks from initial dose given during the ED visit. | 2 Weeks post initial dose |
| Percentage of Continued Abstinence Rate (1 month) | Percentage of subjects who self-report continued abstinence in tobacco use at 1 month from initial dose given during the ED visit. | 1 Month post initial dose |
| Percentage of Continued Abstinence Rate (3 months) | Percentage of subjects who self-report continued abstinence in tobacco use at 3 months from initial dose given during the ED visit. | 3 Months post initial dose |
| Patient Health Questionnaire 2 (Baseline) | A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression. | Baseline |
| Patient Health Questionnaire 2 (3 months from baseline) | A validated instrument to assess the frequency of depression and anhedonia screen for depression, scores can range from 0 to 6, with each item scored from 0 (not at all) to 3 (nearly every day). Scores greater than or equal to typically indicate depression. | 3 months from baseline |
| Heaviness of Smoking Index (Baseline) | A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, >5 is severe) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley End | West Virginia University | Principal Investigator |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| West Virginia Quit Line | Other | Instructional Pamphlets and contact information for the WV QL. A telehealth line set up to assist people of WV to quit smoking. |
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| Baseline |
| Heaviness of Smoking Index (3 months from baseline) | A validated measure used to determine the level of nicotine addiction, with a scale of 0-6 (3 indicates moderate addiction, >5 is severe) | 3 months from baseline |
| Richmond Test (Baseline) | A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit. | Baseline |
| Richmond Test (3 months from baseline) | A validated instrument to assess motivation to quit smoking. This is scored on a 0-10 scale with 5-6 indicating moderate motivation to quit and 7+ indicating strong motivation to quit. | 3 months from baseline |
| D001519 | Behavior |