E-cigarettes for Tobacco Use
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on switching from tobacco to e-cigarettes for those in treatment for opioid use disorder.
What data supports the effectiveness of the treatment E-cigarette for tobacco use?
What safety data exists for e-cigarettes in humans?
E-cigarettes can cause acute nicotine toxicity, and there are concerns about their potential to cause sudden or long-term health effects due to exposure to complex chemicals. While they are marketed as safer alternatives to tobacco, the presence of toxicants and carcinogens in e-cigarette liquid and vapor raises safety concerns.678910
How do e-cigarettes differ from other treatments for tobacco use?
E-cigarettes are unique because they deliver nicotine without the harmful constituents of tobacco smoke, potentially helping smokers quit traditional cigarettes. Unlike other treatments, they simulate smoking by vaporizing nicotine-containing solutions, which may appeal to those who miss the physical act of smoking.1112131415
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants complete a baseline session and are randomly assigned to either receive an e-cigarette product or brief advice to quit smoking
Treatment
Participants receive either NJOY Ace e-cigarettes or brief advice for smoking cessation, with follow-up visits at weeks 2, 6, and 8
Follow-up
Participants are monitored for changes in smoking behavior and intention to quit
Treatment Details
Interventions
- E-cigarette
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor