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Recruiting NCT07202039

Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine

No phase Interventional Tobacco-flavored EC Sweet-Cooling EC Sweet Non-cooling EC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief individual counseling sessions.
Who it may be relevant to
Registry conditions: Tobacco-flavored EC, Sweet-Cooling EC, Sweet Non-cooling EC. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine

Interventions

  • Behavioral Brief individual counseling sessions
    Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC

Primary outcome measures

  • Change in cigarettes smoked per day [Time frame: Baseline to week 12]
Secondary outcome measures (6)
  • Change in cigarettes smoked per day [Time frame: Baseline to week 24]
  • Percentage of participants with a ≥50% reduction in CPD [Time frame: Baseline to weeks 12 and 26]
  • Switching [Time frame: Weeks 12 and 24]
  • Partial Switching [Time frame: Weeks 12 and 24]
  • 7-Day CC Abstinence [Time frame: Weeks 12 and 26]
  • Change in carbon monoxide levels [Time frame: Baselone to weeks 12 and 26]

Eligibility criteria

Inclusion criteria

  • Age ≥21 years
  • Smoke ≥5 CPD for ≥1 year
  • Daily CC smoker
  • Willing to switch to EC
  • Exhaled CO ≥6 ppm
  • Diagnosed with OUD
  • Stable on bupropion treatment
  • In good physical and mental health
  • Able to use a smartphone
  • Willing to participate in all study components
  • Able to provide informed consent Exclusion Criteria
  • Interested in quitting CC (contemplation stage of change)
  • Use of EC on ≥4 of the past 30 days
  • Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days
  • Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days
  • Hypertension
  • Medical condition that would contraindicate participation
  • Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode
  • Current suicidal ideation or suicide attempt in the past year
  • Psychiatric hospitalization in the past year
  • Contemplating pregnancy, currently pregnant, or breastfeeding
  • Unable to speak and/or read English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Addiction Medicine Center — Greenville

Identifiers

NCT: NCT07202039 · 2328661-1 · K01DA062708

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗