E-cigarettes for Harm Reduction in Adults With Opioid Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Prisma Health-Upstate
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percentage of participants who report using the e-cigarette at least once a day
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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)
Arms & Interventions
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.
Intervention: E-cigarette (Other)
Outcomes
Primary Outcomes
Percentage of participants who report using the e-cigarette at least once a day
Time Frame: Week 1 to week 4
Percentage of participants who report using the e-cigarette at least once a day in weeks 1-4
Percentage of people who are eligible
Time Frame: Baseline
Percentage of people who are screened for the study who are eligible and consent to participate in the study
Percentage of consented participants
Time Frame: Through study completion, 1 month follow-up
Percentage of consented participants will complete the study
Percentage of daily diary completed
Time Frame: Week 1 to week 4
Percentage of daily diary entries completed
Percentage of participants with at least one puff of study e-cigarette
Time Frame: Week 1 to week 4
Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4
Secondary Outcomes
- Cigarette demand measured via the cigarette purchase task(Baseline to Week 4)
- Combustible cigarette smoking(Baseline vs week 4)
- Switching to e-cigarettes(week 4)
- Smoking reduction(From baseline to Week 4)
- Cigarette dependence measured via the Fagerstrom test for nicotine dependence(Baseline to week 4)