Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05278065
Other study ID # 1908002509
Secondary ID P20GM130414
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date May 2024

Study information

Verified date November 2023
Source Brown University
Contact Alexander W Sokolovsky, PhD
Phone 4018636629
Email alexander_sokolovsky@brown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States Center for Alcohol and Addiction Studies Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cigarettes per day from baseline to week 8 Past week average cigarettes per day assessed using timeline follow-back (TLFB). Baseline, Week 8
Primary Change in cigarettes per day from week 8 to week 16 Past week average cigarettes per day assessed using timeline follow-back (TLFB). Week 8, Week 16
Primary Change in electronic nicotine delivery system (ENDS) use from baseline to week 8 Past week average ENDS use occasions per day assessed using timeline follow-back (TLFB). Baseline, Week 8
Primary Change in electronic nicotine delivery system (ENDS) use from week 8 to week 16 Past week average ENDS use occasions per day assessed using timeline follow-back (TLFB). Week 8, Week 16
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. Baseline, Week 8
Primary Change in cigarette dependence motives from baseline to week 8 Assessed using the Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-WISDM). Range: 0-7 per subscale (mean of items); higher scores = more evidence of dependence motive. Baseline, Week 8
Primary Change in electronic nicotine delivery system (ENDS) dependence from baseline to week 8 Assessed using the Penn State Dependence Index (PS). Range: 0-20; higher scores = more dependent. Baseline, Week 8
Primary Change in electronic nicotine delivery system (ENDS) dependence motives from baseline to week 8 Assessed using the E-cigarette Wisconsin Inventory for Smoking Dependence Motives - Brief (Brief-eWISDM). Range: 0-7 per subscale (mean of items); higher scores = more evidence of dependence motive. Baseline, Week 8
Primary Change in asthma control from baseline to week 8 Assessed using the Asthma Control Test (ACT). Range: 5 - 25; higher scores = better asthma control. Baseline, Week 8
Primary Change in asthma symptom-related quality of life from baseline to week 8 Assessed using the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ). Range: 0-7 total and per subscale (mean of items); higher scores = less impact on health related quality of life. Baseline, Week 8
Primary Change in asthma symptom-related quality of life from week 8 to week 16 Assessed using the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ). Range: 0-7 total and per subscale (mean of items); higher scores = less impact on health related quality of life. Week 8, Week 16
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). Baseline, Week 8
Primary Change in pulmonary functioning from baseline to week 8 (forced expiratory volume [FEV]) Assessed using spirometry and indexed as percent of predicted normal. Baseline, Week 8
Primary Change in pulmonary functioning from baseline to week 8 (forced vital capacity [FVC]) Assessed using spirometry and indexed as percent of predicted normal. Baseline, Week 8
Primary Change in pulmonary functioning from baseline to week 8 (forced expiratory flow 25%-75% [FEF25-75]) Assessed using spirometry and indexed as percent of predicted normal. Baseline, Week 8
Primary Change in pulmonary functioning from baseline to week 8 (peak expiratory flow 25%-75% [PEF]) Assessed using spirometry and indexed as percent of predicted normal. Baseline, Week 8
Primary Change in carbon monoxide (CO) from baseline to week 8 Level of exhaled CO assessed with Smokerlyzer. Baseline, Week 8
Primary Change in fractional exhaled nitric oxide (FENO) from baseline to week 8 Level of exhaled FENO assessed with NIOX breath sensor. Baseline, Week 8
Primary Change in 4 (Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) from baseline to week 8 Biosample collected via urine and adjusted for creatinine. Baseline, Week 8
Primary Change in cotinine from baseline to week 8 Biosample collected via urine and adjusted for creatinine. Baseline, Week 8
Primary Change in interleukin-6 (IL-6) from baseline to week 8 Biosample collected via blood draw. Baseline, Week 8
Primary Change in tumor necrosis factor alpha (TNF-a) from baseline to week 8 Biosample collected via blood draw. Baseline, Week 8
Primary Change in chemokine ligand 9 (CXCL9) from baseline to week 8 Biosample collected via blood draw. Baseline, Week 8
Primary Change in matrix metallopeptidase 9 (MMP9) from baseline to week 8 Biosample collected via blood draw. Baseline, Week 8
See also
  Status Clinical Trial Phase
Terminated NCT04410523 - Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma Phase 2
Completed NCT04624425 - Additional Effects of Segmental Breathing In Asthma N/A
Active, not recruiting NCT03927820 - A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR) N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT03694158 - Investigating Dupilumab's Effect in Asthma by Genotype Phase 4
Terminated NCT04946318 - Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma Phase 2
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Completed NCT03086460 - A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH) Phase 2
Completed NCT01160224 - Oral GW766944 (Oral CCR3 Antagonist) Phase 2
Completed NCT03186209 - Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE) Phase 3
Completed NCT02502734 - Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma Phase 3
Completed NCT01715844 - L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics Phase 1
Terminated NCT04993443 - First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Phase 1
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT06033833 - Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study Phase 2
Completed NCT03257995 - Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma. Phase 2
Completed NCT02212483 - Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients N/A
Recruiting NCT04872309 - MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
Withdrawn NCT01468805 - Childhood Asthma Reduction Study N/A
Recruiting NCT05145894 - Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device