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Could a health Worker's support break the smoking habit in mental illness?

NCT ID NCT07789132

Disease control Sponsor: Massachusetts General Hospital 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether adding specially trained community health workers to routine mental health care helps people with serious mental illness quit smoking. Participants receive individualized counseling, education, and help with quit goals and medications. The study measures quit rates and changes in heart disease risk over 18 months.

What this could mean

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

Active substance
Integrated Community Health Worker (CHW) support, a behavioral intervention where intensive case managers trained as tobacco treatment specialists provide smoking cessation counseling and support
What this could lead to
If it works, this could offer a practical way to help people with serious mental illness quit smoking, potentially lowering their risk of heart disease and improving mental health.
What could go wrong
The trial is early and the outcome depends on whether the support is more effective than usual care. Quitting smoking is hard, and the benefit may vary widely among participants.

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

About 937 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

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 to 75 years

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: 1. Age 18-75, inclusive 2. Have been diagnosed with SMI that has qualified them for Medicaid behavioral health services (i.e., mood, anxiety, traumatic, and psychotic disorders with or without functional impairment) and receive care through the community human services organizations in Massachusetts. 3. Self-report of past year daily tobacco smoking 4. Able to understand study procedures and communicate in English or Spanish 5. Willingness to participate in a biannual interview with a research coordinator and to meet with a CHW if assigned to one 6. Competent and willing to provide informed consent Exclusion Criteria: 1. Have dementia or intellectual disability (estimated IQ\< 70) 2. Not able to communicate in English or Spanish 3. Unstable medical condition that compromises ability to safely participate, in the investigator's opinion 4. Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion 5. Unwilling to participate in study procedures 6. Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol

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Conditions

The condition(s) this trial relates to.

Behavior, Addictive nicotine dependence psychiatric disorder Smoking Tobacco Use Cessation

As listed by the trial registrant

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

Cardiovascular (CV) risk Community health workers Nicotine dependance Serious mental illness Smoking (tobacco) addiction Tobacco cessation Tobacco use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Addiction Medicine - Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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