Asthma, Cigarette Smoking, Electronic Cigarette Use, Smoking
Conditions
Keywords
Smoking, Vaping, Cigarettes, E-cigarettes, electronic nicotine delivery systems, ENDS, Asthma, Substitution, pulmonary function, harm reduction
Brief summary
Smoking is the main cause of preventable disease and death in the US and impacts respiratory illnesses including COPD and asthma. However, little is known about the effects on smoking and lung health of substituting cigarettes with ENDS in adults with asthma. This project aims to test whether providing ENDS to adults with asthma will lead to substitution of smoking for ENDS, reduced dependence, and improved lung function so such knowledge can inform interventions to reduce the public health burden of tobacco.
Detailed description
This study will use an unequally allocated between-subjects (N=30) randomized, controlled design to investigate the influence of complimentary electronic nicotine delivery system (ENDS) provision on combustible cigarette and ENDS use, cigarette dependence, pulmonary function, clinical indicators and biomarkers, and substitution of smoking for ENDS use over 16 weeks. Participants will be adults from the local community with persistent asthma symptoms who are regular combustible cigarette smokers and do not also regularly use ENDS. The study will recruit 30 non-treatment seeking participants using flyers, advertisements, a website triaging visitors to the Center for Alcohol and Addiction Studies, and through targeted recruitment at community immunology clinic partners at Rhode Island Hospital as facilitated by mentor McQuaid. Participants meeting eligibility criteria will be assessed at baseline and then randomized to one of two study conditions: a complimentary ENDS provision condition or assessment-only control. Participants will return for eight weekly visits to complete follow-up assessments; participants in the experimental condition will be provided with additional e-liquid cartridges for their ENDS devices at all follow-up visits. Tobacco use behaviors (cigarette and ENDS) and lung function will be assessed at each visits, with additional collection of biological samples and assessments of nicotine dependence, self-efficacy for cessation, and mood at week eight. Provision of complimentary ENDS will discontinue eight weeks after enrollment. Participants will complete a remote follow-up assessment sixteen weeks after enrollment. This project, and all projects at the Center for Addiction and Disease Risk Exacerbation (CADRE) are supported by the Clinical Laboratory Core (CLC) which will oversee the collection and storage of data and biological samples.
Interventions
OTHERNicotine
Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment.
Sponsors
National Institute of General Medical Sciences (NIGMS)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
2:1 allocation of experimental to assessment only control
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (50%), 21 to 65 (inclusive) years of age; * Persistent asthma symptoms (i.e., episodic symptoms of airflow obstruction / airway hyperresponsiveness (AHR) as documented in review of medical history); * Currently prescribed SABA medication; * Past-year smoking of ≥5 cigarettes/day; * Exhaled CO ≥ 6 ppm at baseline; * Zero breath alcohol during informed consent for participation; * English-speaking at an 8th grade level.
Exclusion criteria
* Intention to quit smoking during the next 30 days; * Current engagement in any smoking cessation treatment; * Current self-identification as regular ENDS user or using ENDS \> 2 days / week; * Medical contraindication to nicotine; * Pregnancy (due to toxicity of nicotine and tobacco products); * Current alcohol dependence (AUDIT \> 15) * Urine-screened or past-month self-reported use of illicit substances (amphetamine, cocaine, methamphetamine, opioids, benzodiazepines); * Current psychosis, mania, or suicidal ideation;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Baseline, Week 8, Week 16 | Past week average cigarettes per day assessed using timeline follow-back (TLFB). |
| Change in Cigarette Dependence From Baseline to Week 8 | Baseline, Week 8 | Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent. |
| Change in Cigarette Dependence Motives From Baseline to Week 8 | Baseline, Week 8 | Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive. |
| Change in Asthma Symptoms From Baseline to Week 8 | Baseline, Week 8 | Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms). |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Baseline, Week 8 | Assessed using spirometry and indexed in liters. |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Baseline, Week 8 | Assessed using spirometry and indexed in liters. |
| Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Baseline, Week 8 | Assessed using spirometry and indexed as liters per section (L/s). |
| Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Baseline, Week 8 | Assessed using spirometry and indexed in liters per minute (L/min). |
| Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Baseline, Week 8 | Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electronic Cigarette Participants in this experimental condition will be provided with a 4th generation electronic cigarette device and disposable cartridges.
Nicotine: Participants will be provided with electronic cigarettes and 5% nicotine e-liquid cartridges for 8 weeks and encouraged at weekly assessments to use the electronic cigarette any time they would normally smoke. Participants will be able to choose commercially available e-liquid flavors (tobacco) at each weekly assessment. | 12 |
| Smoking As Usual Participants in this assessment-only condition will continue smoking as usual. | 5 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Electronic Cigarette | Total | Smoking As Usual |
|---|---|---|---|
| Age, Continuous | 48.25 years STANDARD_DEVIATION 11.7 | 50.88 years STANDARD_DEVIATION 10.9 | 57.20 years STANDARD_DEVIATION 5.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 10 Participants | 2 Participants |
| Region of Enrollment United States | 12 Participants | 17 Participants | 5 Participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 5 |
| other Total, other adverse events | 1 / 12 | 0 / 5 |
| serious Total, serious adverse events | 0 / 12 | 0 / 5 |
Outcome results
Primary
Change in Asthma Symptoms From Baseline to Week 8
Assessed using the Asthma Symptom Utility Index (ASUI). Range: 0-1 continuous; higher scores = fewer or lighter symptoms (0 = worst possible symptoms, 1 = no symptoms).
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Asthma Symptoms From Baseline to Week 8 | Baseline | 0.71 score on a scale | Standard Deviation 0.18 |
| Electronic Cigarette | Change in Asthma Symptoms From Baseline to Week 8 | Week 8 | 0.61 score on a scale | Standard Deviation 0.21 |
| Smoking As Usual | Change in Asthma Symptoms From Baseline to Week 8 | Week 8 | 0.69 score on a scale | Standard Deviation 0.23 |
| Smoking As Usual | Change in Asthma Symptoms From Baseline to Week 8 | Baseline | 0.65 score on a scale | Standard Deviation 0.23 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.26895% CI: [-0.077, 0.25]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.62495% CI: [-0.291, 0.198]t-test, 2 sided
p-value: 0.17GEE
Primary
Change in Cigarette Dependence From Baseline to Week 8
Assessed using the Fagerstrom Test for Cigarette Dependence (FTCD). Range: 0-10; higher scores = more dependent.
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Cigarette Dependence From Baseline to Week 8 | Baseline | 5.08 score on a scale | Standard Deviation 2.68 |
| Electronic Cigarette | Change in Cigarette Dependence From Baseline to Week 8 | Week 8 | 4.73 score on a scale | Standard Deviation 2.33 |
| Smoking As Usual | Change in Cigarette Dependence From Baseline to Week 8 | Baseline | 5.60 score on a scale | Standard Deviation 2.19 |
| Smoking As Usual | Change in Cigarette Dependence From Baseline to Week 8 | Week 8 | 5.60 score on a scale | Standard Deviation 0.89 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.06895% CI: [-0.07, 1.71]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 195% CI: [-2.32, 2.32]t-test, 2 sided
p-value: 0.44GEE
Primary
Change in Cigarette Dependence Motives From Baseline to Week 8
Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). The value of this outcome variable is the TOTAL SCORE (possible range: 1-7). The TOTAL SCORE is computed as a MEAN of all subscale scores (possible range: 1-7). Each subscale score is the mean of the relevant item scores (possible range: 1-7). Only the TOTAL SCORE is being investigated as an outcome measure. HIGHER SCORES = STRONGER dependence motive.
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Cigarette Dependence Motives From Baseline to Week 8 | Baseline | 4.79 score on a scale | Standard Deviation 0.96 |
| Electronic Cigarette | Change in Cigarette Dependence Motives From Baseline to Week 8 | Week 8 | 4.36 score on a scale | Standard Deviation 1.56 |
| Smoking As Usual | Change in Cigarette Dependence Motives From Baseline to Week 8 | Baseline | 5.41 score on a scale | Standard Deviation 1.69 |
| Smoking As Usual | Change in Cigarette Dependence Motives From Baseline to Week 8 | Week 8 | 4.18 score on a scale | Standard Deviation 2.15 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.14595% CI: [-0.184, 1.078]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.2895% CI: [-1.5, 3.95]t-test, 2 sided
p-value: 0.38GEE
Primary
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Past week average cigarettes per day assessed using timeline follow-back (TLFB).
Time frame: Baseline, Week 8, Week 16
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Week 8 | 9.51 cigarettes per day | Standard Deviation 11.06 |
| Electronic Cigarette | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Week 16 | 8.12 cigarettes per day | Standard Deviation 7.06 |
| Electronic Cigarette | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Baseline | 16.34 cigarettes per day | Standard Deviation 8.68 |
| Smoking As Usual | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Week 8 | 8.66 cigarettes per day | Standard Deviation 6.83 |
| Smoking As Usual | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Week 16 | 12.30 cigarettes per day | Standard Deviation 10 |
| Smoking As Usual | Change in Cigarettes Per Day From Baseline to Week 8 and Week 16 | Baseline | 15.39 cigarettes per day | Standard Deviation 6.43 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.00495% CI: [3.2, 12.98]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.0695% CI: [-0.4, 13.87]t-test, 2 sided
p-value: 0.766GEE
Comparison: Repeated measures analysis at Wk 8 and Wk 16 for experimental armp-value: 0.53395% CI: [-3.41, 6.19]t-test, 2 sided
Comparison: Repeated measures analysis at Wk 8 and Wk 16 for control armp-value: 0.29695% CI: [-12.21, 4.84]t-test, 2 sided
p-value: 0.14GEE
Comparison: Repeated measures analysis at BL and Wk 16 for experimental armp-value: 0.00295% CI: [4.24, 14.71]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.29195% CI: [-3.91, 10.01]t-test, 2 sided
p-value: 0.067GEE
Primary
Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8
Level of exhaled FENO assessed with NIOX breath sensor in parts per billion (PPB).
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Week 8 | 10.9 parts per billion (PPB) | Standard Deviation 8.96 |
| Electronic Cigarette | Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Baseline | 11.6 parts per billion (PPB) | Standard Deviation 10.2 |
| Smoking As Usual | Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Baseline | 9.80 parts per billion (PPB) | Standard Deviation 8.01 |
| Smoking As Usual | Change in Fractional Exhaled Nitric Oxide (FENO) From Baseline to Week 8 | Week 8 | 7.75 parts per billion (PPB) | Standard Deviation 2.36 |
p-value: 0.96595% CI: [-9.25, 8.89]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.52295% CI: [-11.1, 17.6]t-test, 2 sided
p-value: 0.781GEE
Primary
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
Assessed using spirometry and indexed as liters per section (L/s).
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Baseline | 1.91 liters per second (L/s) | Standard Deviation 1 |
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Week 8 | 1.88 liters per second (L/s) | Standard Deviation 0.98 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Baseline | 1.82 liters per second (L/s) | Standard Deviation 0.87 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75]) | Week 8 | 2.12 liters per second (L/s) | Standard Deviation 0.64 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.84995% CI: [-0.483, 0.576]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.10795% CI: [-0.706, 0.102]t-test, 2 sided
p-value: 0.19GEE
Primary
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Assessed using spirometry and indexed in liters.
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Baseline | 2.24 liters | Standard Deviation 0.84 |
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Week 8 | 2.32 liters | Standard Deviation 0.93 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Baseline | 2.41 liters | Standard Deviation 0.53 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV]) | Week 8 | 2.30 liters | Standard Deviation 0.57 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.57495% CI: [-0.374, 0.219]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.07795% CI: [-0.02, 0.252]t-test, 2 sided
p-value: 0.149GEE
Primary
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Assessed using spirometry and indexed in liters.
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Week 8 | 3.13 liters | Standard Deviation 1.16 |
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Baseline | 3.02 liters | Standard Deviation 1 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Baseline | 3.35 liters | Standard Deviation 0.79 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC]) | Week 8 | 2.98 liters | Standard Deviation 0.74 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.37695% CI: [-0.396, 0.163]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.06595% CI: [-0.036, 0.78]t-test, 2 sided
p-value: 0.006GEE
Primary
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])
Assessed using spirometry and indexed in liters per minute (L/min).
Time frame: Baseline, Week 8
Population: 1 participant withdrew from the study between baseline and week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Baseline | 6.50 liters per minute (L/min) | Standard Deviation 2.57 |
| Electronic Cigarette | Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Week 8 | 6.68 liters per minute (L/min) | Standard Deviation 2.91 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Baseline | 6.45 liters per minute (L/min) | Standard Deviation 1.41 |
| Smoking As Usual | Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF]) | Week 8 | 5.69 liters per minute (L/min) | Standard Deviation 1.69 |
Comparison: Repeated measures analysis at BL and Wk 8 for experimental armp-value: 0.82895% CI: [-0.929, 0.76]t-test, 2 sided
Comparison: Repeated measures analysis at BL and Wk 8 for control armp-value: 0.24995% CI: [-0.81, 2.33]t-test, 2 sided
p-value: 0.17GEE