Effects of Electronic Cigarettes in Cigarette Smokers With Mild to Moderate COPD

NCT ID: NCT03379025

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2021-08-31

Brief Summary

This study evaluates the effects of electronic cigarette use on cigarette smoking and markers of tobacco use, as well as respiratory symptoms and function in smokers with mild to moderate chronic obstructive pulmonary disease (COPD). All participants will receive a 12 week supply of electronic cigarettes to use instead of their regular conventional cigarettes.

Detailed Description

Electronic cigarettes are devices that heat a solution containing nicotine to form an aerosol that is then inhaled by the user. Electronic cigarettes are used by many smokers, including smokers with chronic health conditions such as COPD. Given that e-cigarettes are still relatively new, their effects on health are not well defined.

It is important to understand how electronic cigarettes affects symptoms and lung function in smokers with COPD to determine the short-term safety of these products. To do this, an initial step involves observing the extent to which smokers substitute their conventional cigarette use with electronic cigarette use and change their exposure to tobacco use biomarkers.

Conditions

COPD; Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Early Intervention Group

JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks

Group Type: EXPERIMENTAL

Electronic cigarette

Intervention Type: OTHER

electronic cigarette and cartridge refills (also known as pods)

Delayed Intervention Group

After a 12 week period of no electronic cigarette use, JUUL Electronic Cigarettes, nicotine concentration 59 mg/ml, to replace all cigarette use for 12 weeks

Group Type: OTHER

Electronic cigarette

Intervention Type: OTHER

electronic cigarette and cartridge refills (also known as pods)

Interventions

Electronic cigarette

electronic cigarette and cartridge refills (also known as pods)

Intervention Type: OTHER

Other Intervention Names

e-cigarette, JUUL electronic cigarette

Eligibility Criteria

Inclusion Criteria

• At least 10 pack year smoking history
• Daily use of at least 5 cigarettes
• No plan to quit cigarettes in the next 30 days
• Willing to use e-cigarettes
• Diagnosis of COPD (FEV1/forced vital capacity [FVC] <0.70) with mild (FEV1 >80% predicted) or moderate (FEV1 <80% but >50% predicted) airflow limitation (post-bronchodilator); confirmed by spirometry
• English-speaking

Exclusion Criteria

• Past 30-day use of nicotine-containing products (cigars, cigarillos, hookah, electronic cigarettes, smokeless tobacco, nicotine replacement therapy)
• Past 30 day use of inhaled drugs (marijuana, crack)
• Pregnant or breastfeeding
• Planning to become pregnant within the next 3 months or unable to agree to use appropriate contraception during study
• Pulmonary disease other than COPD or asthma
• Ever requiring mechanical ventilation
• 2 or more hospitalizations for COPD in the past 12 months
• Cardiac hospitalization in the past 6 months
• Active chest pain or palpitations
• Uncontrolled hypertension (blood pressure >160/100)
• Oxygen therapy
• Inability or contraindication to perform spirometry (e.g. recent eye, thoracic, or abdominal surgery)
• Known allergy to propylene glycol or vegetable glycerin
• Unable to consent or complete assessments

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sara Kalkhoran

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2017P002418

Identifier Type: -

Identifier Source: org_study_id