E-cigarettes as a Harm Reduction Strategy

NCT06277271 | Completed

• 1 other identifier: 1901611-9
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Cigarette dependence measured via the Fagerstrom test for nicotine dependence

  Baseline to week 4

• 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

Study Arms (1)

E-cigarette

EXPERIMENTAL

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

Interventions

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.

E-cigarette

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• Clemson University: collaborator

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29609, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 26, 2024
• Study Start: June 20, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)