Methadone-Maintained Smokers Switching to E-Cigarettes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nicotine Dependence Electronic Cigarette Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Electronic Cigarettes

Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.

Group Type ACTIVE_COMPARATOR

Electronic Cigarette

Intervention Type DRUG

Electronic Cigarettes are provided to replace tobacco cigarettes

Nicotine Lozenges

Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.

Group Type ACTIVE_COMPARATOR

Nicotine Lozenge

Intervention Type DRUG

Nicotine Lozenges are provided to replace tobacco cigarettes

Interventions

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Electronic Cigarette

Electronic Cigarettes are provided to replace tobacco cigarettes

Intervention Type DRUG

Nicotine Lozenge

Nicotine Lozenges are provided to replace tobacco cigarettes

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No