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Recruiting

NCT Number: NCT07202039

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

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

Recruiting

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Key information

Conditions

Tobacco-flavored EC Behavior Chemically-Induced Disorders Cigarette Smoking Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Smoking Substance-Related Disorders Sweet Non-cooling EC Sweet-Cooling EC Tobacco Smoking Tobacco Use Vaping

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addiction Medicine Center

Greenville, South Carolina, 29605, United States

Location status: Recruiting

Location contact

Alain Litwin, MD

CONTACT

[email protected]

864-455-5648

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Brief individual counseling sessions

Behavioral

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

Primary outcomes

  1. Change in cigarettes smoked per day

    Time frame: Baseline to week 12

    The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12

Secondary outcomes

  1. Change in cigarettes smoked per day

    Time frame: Baseline to week 24

    The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24

  2. Percentage of participants with a ≥50% reduction in CPD

    Time frame: Baseline to weeks 12 and 26

    The rate of participants achieving an average ≥50% reduction in CPD from baseline (week 0) to weeks 12 and 26, based on a 7-day TLFB

  3. Switching

    Time frame: Weeks 12 and 24

    Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO <6 ppm.

  4. Partial Switching

    Time frame: Weeks 12 and 24

    Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD.

  5. 7-Day CC Abstinence

    Time frame: Weeks 12 and 26

    Percentage of participants with biochemically verified 7-day abstinence (1 = abstinent, 0 = non-abstinent). Defined as self-reported no CC use on a 7-day TLFB with CO <6 ppm.

  6. Change in carbon monoxide levels

    Time frame: Baselone to weeks 12 and 26

    Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable).

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Pericot-Valverde, PhD

CONTACT

[email protected]

(864)656-4467

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: SWITCH

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Oct 1, 2025
Registry last updated
May 12, 2026

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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