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E-cigarette Switching Older Adults

NCT06534905 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-11-05

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if adults 50 years and older who currently smoke tobacco and are in treatment for opioid use disorder will switch to using e-cigarettes instead of continued smoking. Participants will not have a plan to quit smoking and will not be actively trying to quit smoking at the start of the trial. The main questions the study aims to answer are:

* Are e-cigarettes a feasible and acceptable harm-reduction tool among older adults who currently smoke tobacco and don\'t have a plan to quit?
* Will switching to e-cigarettes and reducing tobacco use be more likely among patients given access to e-cigarettes compared to individuals who are exposed to a standard brief intervention for smoking cessation (control)?
* Does the accuracy of nicotine/tobacco knowledge change after participants are exposed to education on the harms of nicotine relative to no education?

Participants will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8, each lasting 30-90 minutes, for a total of approximately 3-4 hours of participation in the study. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning.

Patients will be randomly assigned at baseline (if meeting eligibility criteria) to receive an e-cigarette product (name of product: NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).

Conditions

Interventions

OTHER

E-cigarette

Each participant assigned to the e-cigarette group will given a rechargeable NJOY Ace e-cigarette that is either tobacco or mint-flavored (based on their preference). Participants will also be given disposable pods prefilled with nicotine. When the pod is empty, the participant will throw it away and replace it with a new pod provided by the study staff. Participants will be asked to use as little or as much of the e-cigarette during their study participation, including choosing not to use the product. Participants will also be given information on the relative harms of nicotine and tobacco products as recommended by the American Society of Addiction Medicine.

BEHAVIORAL

Control/Standard Advice

Brief advice to quit according recommendations from the American Society of Addiction Medicine

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-25
Primary Completion
2025-10-09
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534905 on ClinicalTrials.gov