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Digital coaching may help smokers with mental illness stay quit after hospital discharge

NCT ID NCT04367506

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests a digital smoking cessation program called BecomeAnEx, adapted for people with serious mental illness who want to quit or reduce smoking. Participants use a website, text messaging, and real-time coaching from a remote quit-smoking expert, plus an online community. The goal is to help them stay smoke-free after leaving the hospital, where they were temporarily abstinent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a digital smoking cessation program called BecomeAnEx, which includes a website, text messaging, real-time coaching, and an online community
What this could lead to
If successful, this approach could help many people with serious mental illness stay smoke-free after leaving the hospital, reducing smoking-related health risks.
What could go wrong
This is a small pilot study with only 59 participants, so results may not apply to everyone. The program's success depends on internet access and personal motivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

59 people

The number who actually took part.

Started

Sep 2022

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 or greater * Diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression) * Current smoker \[prior to admission, smoked at least one cigarette or small cigar per day in the past month (unless restricted, e.g. due to ER/hospital visit) and smoked at least 100 cigarettes lifetime\] * Interested in remaining quit after hospital discharge or quitting within the following 30 days * Expected Internet use at least 3 times/week post-discharge and ownership of mobile device with text messaging plan post-discharge. * Discharge destination within 1-hour of SPH given that Aim 3 involves biochemical verification (carbon monoxide testing). * Reading competence as demonstrated by a score of \>= 37 on the Word Reading subtest of the Wide Range Achievement Test - 4th Edition (WRAT-4)168 to ensure the ability to engage in the intervention. Exclusion Criteria: * Intellectual disability (DSM5 317, 318), traumatic brain injury, or deafness. * Homeless prior to admission or anticipated to be homeless at discharge. * Discharge to a residential setting where smoking is prohibited. * Medical condition for which the use of nicotine replacement therapy (NRT) is contraindicated including pregnant, planning to become pregnant, or breastfeeding; within 4 weeks post myocardial infarction; severe arrhythmia, severe angina pectoris; peptic ulcer; severe renal failure; poorly controlled insulin-dependent diabetes; severely uncontrolled hypertension; peripheral vascular disease.

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Conditions

The condition(s) this trial relates to.

Tobacco Use Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tobacco cessation

Contacts and locations

Locations

  • Melanie Bennett

    Baltimore, Maryland, 21021, United States

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201, United States

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