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| Name | Class |
|---|---|
| Clemson University | OTHER |
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E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.
Between 84-94% of individuals with opioid use disorder (OUD) smoke cigarettes, a rate six times higher than the general US adult population. Despite the majority of smokers with OUD expressing motivation to quit, cessation rates remain extremely low, even with evidence-based medications. E-cigarettes have emerged as a harm reduction strategy for smokers unable or unwilling to quit. Research on the effectiveness of e-cigarettes for smoking reduction among individuals with OUD on buprenorphine/methadone maintenance treatment is scarce but promising. This study is an open-label single-arm clinical trial testing the use of e-cigarettes as a harm reduction strategy among smokers with OUD on buprenorphine in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette | Experimental | Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette | Other | Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of people who are eligible | Percentage of people who are screened for the study who are eligible and consent to participate in the study | Baseline |
| Percentage of consented participants | Percentage of consented participants will complete the study | Through study completion, 1 month follow-up |
| Percentage of participants who report using the e-cigarette at least once a day | Percentage of participants who report using the e-cigarette at least once a day in weeks 1-4 | Week 1 to week 4 |
| Percentage of participants with at least one puff of study e-cigarette | Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4 | Week 1 to week 4 |
| Percentage of daily diary completed | Percentage of daily diary entries completed | Week 1 to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarette dependence measured via the Fagerstrom test for nicotine dependence | Change in cigarette dependence- baseline vs. week 4 | Baseline to week 4 |
| Cigarette demand measured via the cigarette purchase task |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prisma Health | Greenville | South Carolina | 29609 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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Change in cigarette demand- baseline vs. week 4
| Baseline to Week 4 |
| Combustible cigarette smoking | Change in average number of cigarettes consumed- baseline vs week 4 | Baseline vs week 4 |
| Switching to e-cigarettes | Percent of participants who switch to e-cigarettes by the end of week 4 | week 4 |
| Smoking reduction | Percent of participants who change their smoking by at least 50% | From baseline to Week 4 |