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
Not provided
The objective of this clinical trial was to compare the effects of e-cigarettes with and without nicotine on patterns of combustible cigarette use and biomarkers of exposure to tobacco toxicants among African American smokers.
This study compares patterns of e-cigarette use and the exposure to the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in African American smokers, randomized to ad lib e-cigarettes containing nicotine vs. no nicotine. We hypothesized that nicotine e-cigarettes would be used more than no-nicotine e-cigarettes, and that this would be associated with reduced use of combustible cigarettes. We hypothesized that nicotine e-cigarettes would result in more substitution for combusted cigarettes than no-nicotine e-cigarettes and result in lower levels of exposure to the tobacco-specific carcinogen NNAL. These results would be relevant for developing exposure reduction strategies for adult African American smokers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cig Zero Nicotine | Sham Comparator | E-Cigarette with no nicotine added |
|
| E-Cig 24mg Nicotine | Active Comparator | E-cigarette with 24mg of nicotine added |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Cig Zero Nicotine | Device | E-Cig Zero Nicotine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Biomarker Concentrations: Nicotine Equivalents | Change in concentration of nicotine equivalents in units of mmol/mg creatinine. | Baseline, Week 6 |
| Change in Biomarker Concentrations: NNAL | Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine. | Baseline, Week 6 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Cigarettes Per Day | Participants will record the average number of cigarettes smoked per day in the 7 days leading up to each study visit. Outcome is reported as the change in average cigarettes per day from baseline to 6 weeks of treatment. | Baseline, Week 6 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anne Joseph, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCRU | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34669956 | Derived | Okuyemi KS, Ojo-Fati O, Aremu TO, Friedrichsen SC, Grude L, Oyenuga M, Shyne M, Murphy SE, Hatsukami D, Joseph AM. A Randomized Trial of Nicotine versus No-nicotine E-cigarettes Among African American Smokers: Changes in Smoking and Tobacco Biomarkers. Nicotine Tob Res. 2022 Mar 1;24(4):555-563. doi: 10.1093/ntr/ntab212. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | E-Cig Zero Nicotine | E-Cigarette with no nicotine added E-Cig Zero Nicotine: E-Cig Zero Nicotine |
| FG001 | E-Cig 24mg Nicotine | E-cigarette with 24mg of nicotine added E-Cig 24mg Nicotine: E-Cig 24mg Nicotine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 participants in each group withdrew from the study and were not included in the baseline characteristic data.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | E-Cig Zero Nicotine | E-Cigarette with no nicotine added E-Cig Zero Nicotine: E-Cig Zero Nicotine |
| BG001 | E-Cig 24mg Nicotine | E-cigarette with 24mg of nicotine added E-Cig 24mg Nicotine: E-Cig 24mg Nicotine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Biomarker Concentrations: Nicotine Equivalents | Change in concentration of nicotine equivalents in units of mmol/mg creatinine. | Posted | Mean | Standard Deviation | mmol/mg creatinine | Baseline, Week 6 |
|
|
24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-Cig Zero Nicotine | E-Cigarette with no nicotine added E-Cig Zero Nicotine: E-Cig Zero Nicotine |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Joseph, MD, MPH | University of Minnesota | 612-625-3789 | lagre010@umn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2019 | Mar 6, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2017 | Mar 6, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Blocked randomization, block size unknown to staff or investigators
Not provided
Not provided
All participants are blinded to intervention group
| E-Cig 24mg Nicotine |
| Device |
E-Cig 24mg Nicotine |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Change in Biomarker Concentrations: NNAL | Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine. | Posted | Mean | Standard Deviation | pmol/mg creatinine | Baseline, Week 6 |
|
|
|
| Other Pre-specified | Change in Average Cigarettes Per Day | Participants will record the average number of cigarettes smoked per day in the 7 days leading up to each study visit. Outcome is reported as the change in average cigarettes per day from baseline to 6 weeks of treatment. | Posted | Mean | Standard Deviation | cigarettes/day | Baseline, Week 6 |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | E-Cig 24mg Nicotine | E-cigarette with 24mg of nicotine added E-Cig 24mg Nicotine: E-Cig 24mg Nicotine | 0 | 109 | 0 | 109 | 0 | 109 |
Not provided
Not provided
Not provided