E-cigarettes as a Harm Reduction Strategy

Prisma Health-Upstate

Status: Completed

Conditions: Smoking

Treatments: Other: E-cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT06277271

1901611-9

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

E-cigarette

Experimental group

Description:

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.

Treatment:

Other: E-cigarette