Skip to content

E-cigarette Switching Older Adults

Pilot Randomized Controlled Trial of E-cigarette Switching Among Older Adults With Opioid Use Disorder

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06534905
Enrollment
36
Registered
2024-08-02
Start date
2024-11-25
Completion date
2025-10-31
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder, Tobacco-Related Disorders, Tobacco Use

Keywords

e-cigarette

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).

Detailed description

Volunteers will be patients diagnosed with opioid use disorder (OUD) who have been in medication-based treatment (methadone or buprenorphine) at the University of Maryland Addiction Treatment Center (UMATC) at 1001 W Pratt Street for at least 3 months. The 3-month requirement will help to ensure that patients who enroll in this study have been stabilized on methadone and buprenorphine, which are first-line, evidence-based treatments for OUD. All procedures associated with this study will be conducted at the UMATC. After completion of brief pre-screen questions to determine eligibility (i.e., age, tobacco use status, and plans to quit smoking), patients will complete a baseline session (BL) and follow-up visits at weeks 2, 6, and 8 lasting between 30-90 minutes each with a total time of participation in the study of approximately 3-4 hours. Each session will include computerized assessments of tobacco and other substance use, health status, mood, and functioning. In addition, patients will be asked to provide a sample of their breath by breathing into a handheld device that measures air breath carbon monoxide levels. At baseline, participants will be randomly assigned using a number generator to one of two conditions during the baseline session. 1\) standard, brief advice for motivating patients to quit (including linkage to a smoking cessation phone quitline) or 2) education on tobacco harms and provisions of NJOY Ace e-cigarette (menthol or tobacco flavor depending on patient preference). NJOY Ace e-cigarettes are a consumer product that has been authorized by the United States Food and Drug Administration. 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.

Interventions

OTHERE-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.

BEHAVIORALControl/Standard Advice

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

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. 50 years or older; currently in treatment for opioid use disorder for at least 3 months 2. currently use tobacco (\>100 cigarettes in lifetime and smoke every day or some days) 3. xpired air CO \>8ppm 4. does not regularly use e-cigarettes (regular use defined as use in the past month for 2 or more consecutive days) 5. not pregnant or breastfeeding

Exclusion criteria

1. individuals trying to stop smoking or have a plan to quit smoking 2. people age 49 or younger 3. people who do not currently smoke tobacco

Design outcomes

Primary

MeasureTime frameDescription
Intention to quit smoking in next monthup to 8 weeksMeasured by self-report in response to following question "Do you intend to stop smoking in the next month?"
Change in cigarettes smoked per day (percent change)up to 8 weeksMeasured by self-report during study sessions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026