E-cigarettes as a Harm Reduction Strategy

Prisma Health-Upstate30 enrolled

Overview

E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.

Between 84-94% of individuals with opioid use disorder (OUD) smoke cigarettes, a rate six times higher than the general US adult population. Despite the majority of smokers with OUD expressing motivation to quit, cessation rates remain extremely low, even with evidence-based medications. E-cigarettes have emerged as a harm reduction strategy for smokers unable or unwilling to quit. Research on the effectiveness of e-cigarettes for smoking reduction among individuals with OUD on buprenorphine/methadone maintenance treatment is scarce but promising. This study is an open-label single-arm clinical trial testing the use of e-cigarettes as a harm reduction strategy among smokers with OUD on buprenorphine in a real-world setting.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Smoking

Interventions

E-cigaretteOTHER

Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (age ≥21) * Report smoking ≥ 5 cigarettes per day for ≥ one year * Interested in switching to e-cigarettes (self-reported) * OUD diagnosis (DSM-V)(chart review) * Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review) * Plan to remain on buprenorphine for at least 3 months (duration of the study) (self-reported) * Have a smartphone with internet access Exclusion Criteria: * Use of other tobacco or nicotine products other than cigarettes (≥9 days in the past 30) * Used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression) (self-reported) (3) * Having a severe medical condition, including decompensated cirrhosis, severe cardiovascular * disease (myocardial infarction, percutaneous transluminal coronary angioplasty, unstable angina, coronary artery bypass graft, and/or serious arrhythmia in the * prior 6 months) (chart review) * Having severe asthma or chronic obstructive pulmonary disease requiring supplemental oxygen or hospitalization in the past 6 months (chart review) * Being hospitalized for human immunodeficiency virus/acquired immunodeficiency syndromes-related illness in the past 6 months (chart * review) * Having a history of seizure disorder (chart review) * Pregnancy (chart review) or breast-feeding (self-reported) for female participants * Having current DSM-V criteria for mania, psychosis, or major depressive disorder (chart review) * Current suicidal ideation or past year suicide attempt (PHQ-9; see protections against risk) * Being hospitalized for psychiatric reasons in the past year (chart review) * Being unable to independently read and/or comprehend the consent form or other study materials (unable to read study materials aloud) * Being unable to read/speak English (inability to read and complete study materials)

Locations (1)

Prisma Health

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Percentage of people who are eligible

Percentage of people who are screened for the study who are eligible and consent to participate in the study

Time frame: Baseline

Percentage of consented participants

Percentage of consented participants will complete the study

Time frame: Through study completion, 1 month follow-up

Percentage of participants who report using the e-cigarette at least once a day

Percentage of participants who report using the e-cigarette at least once a day in weeks 1-4

Time frame: Week 1 to week 4

Percentage of participants with at least one puff of study e-cigarette

Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4

Time frame: Week 1 to week 4

Percentage of daily diary completed

Percentage of daily diary entries completed

Time frame: Week 1 to week 4

Secondary Outcomes

Cigarette dependence measured via the Fagerstrom test for nicotine dependence

Change in cigarette dependence- baseline vs. week 4

Time frame: Baseline to week 4

Cigarette demand measured via the cigarette purchase task

Change in cigarette demand- baseline vs. week 4

Time frame: Baseline to Week 4

Combustible cigarette smoking

Data from ClinicalTrials.gov

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