Clinical trial NCT06277271: E-cigarettes as a Harm Reduction Strategy
Official title: E-cigarettes for Harm Reduction in Adults With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2024-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of people who are eligible
timeFrame: Baseline
measure: Percentage of consented participants
timeFrame: Through study completion, 1 month follow-up
measure: Percentage of participants who report using the e-cigarette at least once a day
timeFrame: Week 1 to week 4
measure: Percentage of participants with at least one puff of study e-cigarette
timeFrame: Week 1 to week 4
measure: Percentage of daily diary completed
timeFrame: Week 1 to week 4
Secondary outcomes:
measure: Cigarette dependence measured via the Fagerstrom test for nicotine dependence
timeFrame: Baseline to week 4
measure: Cigarette demand measured via the cigarette purchase task
timeFrame: Baseline to Week 4
measure: Combustible cigarette smoking
timeFrame: Baseline vs week 4
measure: Switching to e-cigarettes
timeFrame: week 4
measure: Smoking reduction
timeFrame: From baseline to Week 4
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
References: