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E-cigarette switching for Tobacco Use

N/A
Waitlist Available
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 50 years or older; currently in treatment for opioid use disorder for at least 3 months; currently use tobacco (\>100 cigarettes in lifetime and smoke every day or some days); expired air CO \>8ppm; does not regularly use e-cigarettes (regular use defined as use in the past month for 2 or more consecutive days); not pregnant or breastfeeding
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks
Awards & highlights

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 (NJOY Ace) or brief advice to quit smoking (in alignment with recommendations by the American Society of Addiction Medicine).

Who is the study for?
This trial is for adults aged 50 and older who smoke tobacco and are being treated for opioid use disorder. They should not have any current plans or efforts to quit smoking. The study excludes individuals who do not meet these specific criteria.
What is being tested?
The study tests if providing e-cigarettes can help older adults switch from smoking tobacco to using e-cigarettes, as a harm-reduction tool. It compares the effectiveness of e-cigarettes with standard advice on quitting smoking over several weeks through follow-up visits.
What are the potential side effects?
While the description does not list specific side effects, common concerns with e-cigarette use include throat irritation, coughing, dry mouth, and dependence on nicotine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intention to quit smoking in next month
Reduction in cigarettes smoked per day (% change)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: E-cigarette switchingExperimental Treatment1 Intervention
NJOY Ace e-cigarette (menthol or tobacco flavor, depending on patient preference) to be used ad libitum.
Group II: Standard brief advice to address tobacco useActive Control1 Intervention
Patients will be exposed to a brief smoking cessation intervention (BI) based on long-standing tobacco treatment guidelines (Fiore, 2008) and recommendations in the newly revised 4th edition of the ASAM. If a patient reports wanting to stop smoking, they will be instructed to reach out to their medical provider at the treatment clinic. They will be given multiple state and federal resources for quitting smoking. If the patient does not want to quit smoking during the brief intervention, we will check with them during the next session about their interest. The brief smoking intervention will be delivered at each session to check on individuals who are attempting to quit and to possibly motivate those who aren't quitting to initiate a quit attempt.

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Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
700 Previous Clinical Trials
377,831 Total Patients Enrolled
1 Trials studying Tobacco Use
32 Patients Enrolled for Tobacco Use
~27 spots leftby Aug 2025