E-cigarettes for Harm Reduction in Adults With Asthma (NCT05278065) | Clinical Trial Compass
CompletedNot Applicable
E-cigarettes for Harm Reduction in Adults With Asthma
United States17 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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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;
What they're measuring
1
Change in Cigarettes Per Day From Baseline to Week 8 and Week 16
Timeframe: Baseline, Week 8, Week 16
2
Change in Cigarette Dependence From Baseline to Week 8
Timeframe: Baseline, Week 8
3
Change in Cigarette Dependence Motives From Baseline to Week 8
Timeframe: Baseline, Week 8
4
Change in Asthma Symptoms From Baseline to Week 8
Timeframe: Baseline, Week 8
5
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Volume [FEV])
Timeframe: Baseline, Week 8
6
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Vital Capacity [FVC])
Timeframe: Baseline, Week 8
7
Change in Pulmonary Functioning From Baseline to Week 8 (Forced Expiratory Flow 25%-75% [FEF25-75])
Timeframe: Baseline, Week 8
8
Change in Pulmonary Functioning From Baseline to Week 8 (Peak Expiratory Flow [PEF])