Biomarkers
Conditions
Keywords
smoking, electronic cigarettes, nicotine
Brief summary
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.
Detailed description
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.
Interventions
DEVICEE-Cig Zero Nicotine
E-Cig Zero Nicotine
DEVICEE-Cig 24mg Nicotine
E-Cig 24mg Nicotine
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
All participants are blinded to intervention group
Intervention model description
Blocked randomization, block size unknown to staff or investigators
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. self-identify as African American or Black; 2. age 18 years or older; 3. smoke at least five cigarettes daily for the past year; 4. not interested in quitting smoking in the next 6 months; 5. Willing to use e-cigarettes; 6. Good physical health (no unstable medical or mental health condition); 7. no contraindications for e-cigarette use.
Exclusion criteria
1. Recent unstable or untreated psychiatric diagnosis including substance abuse, as determined by the DSM-IV criteria; 2. use in the past 30 days of tobacco or nicotine products including e-cigarettes, other than regular cigarettes; 3. participation in a smoking cessation program in the past 30 days; 4. pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biomarker Concentrations: Nicotine Equivalents | Baseline, Week 6 | Change in concentration of nicotine equivalents in units of mmol/mg creatinine. |
| Change in Biomarker Concentrations: NNAL | Baseline, Week 6 | Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Cigarettes Per Day | Baseline, Week 6 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E-Cig Zero Nicotine E-Cigarette with no nicotine added
E-Cig Zero Nicotine: E-Cig Zero Nicotine | 114 |
| E-Cig 24mg Nicotine E-cigarette with 24mg of nicotine added
E-Cig 24mg Nicotine: E-Cig 24mg Nicotine | 116 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 7 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | E-Cig 24mg Nicotine | Total | E-Cig Zero Nicotine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 11 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 219 Participants | 107 Participants |
| Age, Continuous | 50.89 years STANDARD_DEVIATION 10.74 | 50.81 years STANDARD_DEVIATION 11.18 | 50.74 years STANDARD_DEVIATION 11.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 113 Participants | 224 Participants | 111 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 116 participants | 230 participants | 114 participants |
| Sex: Female, Male Female | 51 Participants | 101 Participants | 50 Participants |
| Sex: Female, Male Male | 65 Participants | 129 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 106 | 0 / 109 |
| other Total, other adverse events | 0 / 106 | 0 / 109 |
| serious Total, serious adverse events | 0 / 106 | 0 / 109 |
Outcome results
Primary
Change in Biomarker Concentrations: Nicotine Equivalents
Change in concentration of nicotine equivalents in units of mmol/mg creatinine.
Time frame: Baseline, Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cig Zero Nicotine | Change in Biomarker Concentrations: Nicotine Equivalents | 74.9 mmol/mg creatinine | Standard Deviation 57.23 |
| E-Cig 24mg Nicotine | Change in Biomarker Concentrations: Nicotine Equivalents | 79.56 mmol/mg creatinine | Standard Deviation 72.8 |
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.
Time frame: Baseline, Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cig Zero Nicotine | Change in Biomarker Concentrations: NNAL | 1.98 pmol/mg creatinine | Standard Deviation 1.74 |
| E-Cig 24mg Nicotine | Change in Biomarker Concentrations: NNAL | 1.95 pmol/mg creatinine | Standard Deviation 1.47 |
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.
Time frame: Baseline, Week 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| E-Cig Zero Nicotine | Change in Average Cigarettes Per Day | 8.8 cigarettes/day | Standard Deviation 6.3 |
| E-Cig 24mg Nicotine | Change in Average Cigarettes Per Day | 8.6 cigarettes/day | Standard Deviation 6.3 |