Methadone-Maintained Smokers Switching to E-Cigarettes

Phase 4Active Not RecruitingNCT05206435

Butler Hospital240 enrolled

Overview

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.

Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment. All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT. This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Nicotine Dependence Electronic Cigarette Use

Interventions

Electronic CigaretteDRUG

Electronic Cigarettes are provided to replace tobacco cigarettes

Nicotine LozengeDRUG

Nicotine Lozenges are provided to replace tobacco cigarettes

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath CO \> 10 ppm) * have been receiving methadone for at least three months * attend at least weekly to receive methadone dose * speak English * have a telephone or access to a telephone * are available over the next 6 weeks * are interested in switching to either electronic cigarettes or nicotine replacement therapy Exclusion Criteria: * use of ECs on \> 2 of the past 30 days * currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT) * have unstable psychiatric conditions * have near-daily or daily use of marijuana * are pregnant * had a cardiovascular event in the last month * daily medication for asthma or COPD

Locations (1)

Butler Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Nicotine Exposure

Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks.

Time frame: 6 weeks

FVC Lung Functioning

Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks.

Time frame: 6 weeks

FEV1 Lung Functioning

Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks.

Time frame: 6 weeks

FEV1/FVC Ratio Lung Functioning

Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks.

Time frame: 6 weeks

Smoking Behavior and Experiences

Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks.

Time frame: 6 weeks

Nicotine Exposure for Complete Switchers

Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-week among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

Time frame: 6 weeks

FVC Lung Functioning for Complete Switchers

Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.

Data from ClinicalTrials.gov

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