E-cigarettes as a Harm Reduction Strategy

E-cigarettes for Harm Reduction in Adults With Opioid Use Disorder

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: E-cigarette

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29609
      • Prisma Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: E-cigarette; 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.

Other: E-cigarette; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
Percentage of consented participants	Percentage of consented participants will complete the study	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	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	Week 1 to week 4
Percentage of daily diary completed	Percentage of daily diary entries completed	Week 1 to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cigarette dependence measured via the Fagerstrom test for nicotine dependence	Change in cigarette dependence- baseline vs. week 4	Baseline to week 4
Cigarette demand measured via the cigarette purchase task	Change in cigarette demand- baseline vs. week 4	Baseline to Week 4
Combustible cigarette smoking	Change in average number of cigarettes consumed- baseline vs week 4	Baseline vs week 4
Switching to e-cigarettes	Percent of participants who switch to e-cigarettes by the end of week 4	week 4
Smoking reduction	Percent of participants who change their smoking by at least 50%	From baseline to Week 4

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Actual): March 18, 2024
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1901611-9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No