E-cigarettes as a Harm Reduction Strategy

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277271
• Other study ID #: 1901611-9
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: March 20, 2024

Study information

• Verified date: January 2024
• Source: Prisma Health-Upstate
• Contact: Irene Pericot-Valverde
• Phone: 8549998005
• Email: iperico[@]clemson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Prisma Health	Greenville	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of consented participants	Percentage of consented participants will complete the study	Through study completion, 1 month follow-up
Primary	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
Primary	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
Primary	Percentage of daily diary completed	Percentage of daily diary entries completed	Week 1 to week 4
Secondary	Cigarette dependence measured via the Fagerstrom test for nicotine dependence	Change in cigarette dependence- baseline vs. week 4	Baseline to week 4
Secondary	Cigarette demand measured via the cigarette purchase task	Change in cigarette demand- baseline vs. week 4	Baseline to Week 4
Secondary	Combustible cigarette smoking	Change in average number of cigarettes consumed- baseline vs week 4	Baseline vs week 4
Secondary	Switching to e-cigarettes	Percent of participants who switch to e-cigarettes by the end of week 4	week 4
Secondary	Smoking reduction	Percent of participants who change their smoking by at least 50%	From baseline to Week 4