E-cigarette Switching Older Adults

NCT06534905 | Active Not Recruiting

• 1 other identifier: HP-00110720
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Tobacco Use; Opioid Use Disorder; Tobacco-Related Disorders

Keywords

e-cigarette

Outcome Measures

Primary Outcomes (2)

• Intention to quit smoking in next month

  Measured by self-report in response to following question "Do you intend to stop smoking in the next month?"

  up to 8 weeks

• Change in cigarettes smoked per day (percent change)

  Measured by self-report during study sessions

  up to 8 weeks

Study Arms (2)

E-cigarette switching

ACTIVE COMPARATOR

NJOY Ace e-cigarette (menthol or tobacco flavor, depending on patient preference) to be used ad libitum.

Other: E-cigarette

Standard brief advice to address tobacco use

OTHER

Usual Care/Treatment As Usual 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.

Behavioral: Control/Standard Advice

Interventions

E-cigarette OTHER

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.

Also known as: ENDS, vaporized nicotine

E-cigarette switching

Control/Standard Advice BEHAVIORAL

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

Standard brief advice to address tobacco use

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• xpired 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

You may not qualify if:

• individuals trying to stop smoking or have a plan to quit smoking
• people age 49 or younger
• people who do not currently smoke tobacco

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Addiction Treatment Center (UMATC)

Baltimore, Maryland, 21223, United States

Location

MeSH Terms

Conditions

Tobacco Use; Opioid-Related Disorders; Vaping

Interventions

Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Maryland School of Medicine

Model Details: Intervention is an e-cigarette (not an FDA approved treatment)

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: November 25, 2024
• Primary Completion: October 9, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)