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OpenTrials
Completed

NCT Number: NCT06277271

E-cigarettes as a Harm Reduction Strategy

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.

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Key information

Conditions

Smoking Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

E-Cigarette

Other

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.

Primary outcomes

  1. 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

  2. Percentage of consented participants

    Time frame: Through study completion, 1 month follow-up

    Percentage of consented participants will complete the study

  3. 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

  4. 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

  5. Percentage of daily diary completed

    Time frame: Week 1 to week 4

    Percentage of daily diary entries completed

Secondary outcomes

  1. Cigarette dependence measured via the Fagerstrom test for nicotine dependence

    Time frame: Baseline to week 4

    Change in cigarette dependence- baseline vs. week 4

  2. Cigarette demand measured via the cigarette purchase task

    Time frame: Baseline to Week 4

    Change in cigarette demand- baseline vs. week 4

  3. Combustible cigarette smoking

    Time frame: Baseline vs week 4

    Change in average number of cigarettes consumed- baseline vs week 4

  4. Switching to e-cigarettes

    Time frame: week 4

    Percent of participants who switch to e-cigarettes by the end of week 4

  5. Smoking reduction

    Time frame: From baseline to Week 4

    Percent of participants who change their smoking by at least 50%

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Clemson University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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