Smoking
Conditions
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.
Interventions
OTHERE-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.
Sponsors
Clemson University
Prisma Health-Upstate
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of daily diary completed | Week 1 to week 4 | Percentage of daily diary entries completed |
| Percentage of people who are eligible | Baseline | Percentage of people who are screened for the study who are eligible and consent to participate in the study |
| Percentage of consented participants | Through study completion, 1 month follow-up | Percentage of consented participants will complete the study |
| Percentage of participants who report using the e-cigarette at least once a day | 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 participants with at least one puff of study e-cigarette | Week 1 to week 4 | Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarette dependence measured via the Fagerstrom test for nicotine dependence | Baseline to week 4 | Change in cigarette dependence- baseline vs. week 4 |
| Cigarette demand measured via the cigarette purchase task | Baseline to Week 4 | Change in cigarette demand- baseline vs. week 4 |
| Combustible cigarette smoking | Baseline vs week 4 | Change in average number of cigarettes consumed- baseline vs week 4 |
| Switching to e-cigarettes | week 4 | Percent of participants who switch to e-cigarettes by the end of week 4 |
| Smoking reduction | From baseline to Week 4 | Percent of participants who change their smoking by at least 50% |
Countries
United States
Outcome results
None listed