Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K01DA062708 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sweet-Cooling EC + Counseling | Experimental | Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
|
| Sweet non-cooling EC + Counseling | Experimental | Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
|
| Tobacco-flavored EC + Counseling | Active Comparator | Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief individual counseling sessions | Behavioral | Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cigarettes smoked per day | The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12 | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cigarettes smoked per day | The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24 | Baseline to week 24 |
| Percentage of participants with a ≥50% reduction in CPD |
Not provided
Inclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Pericot-Valverde, PhD | Contact | (864)656-4467 | iperico@clemson.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Addiction Medicine Center | Recruiting | Greenville | South Carolina | 29605 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D009293 | Opioid-Related Disorders |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D000079524 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The rate of participants achieving an average ≥50% reduction in CPD from baseline (week 0) to weeks 12 and 26, based on a 7-day TLFB
| Baseline to weeks 12 and 26 |
| Switching | Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO <6 ppm. | Weeks 12 and 24 |
| Partial Switching | Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD. | Weeks 12 and 24 |
| 7-Day CC Abstinence | Percentage of participants with biochemically verified 7-day abstinence (1 = abstinent, 0 = non-abstinent). Defined as self-reported no CC use on a 7-day TLFB with CO <6 ppm. | Weeks 12 and 26 |
| Change in carbon monoxide levels | Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable). | Baselone to weeks 12 and 26 |
| Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |