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E-Cigs plus coaching may help mentally ill smokers cut harm

NCT ID NCT06543407

Disease control Sponsor: Dartmouth-Hitchcock Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving e-cigarettes to smokers with mental illness—along with optional behavioral coaching—helps them switch from regular cigarettes and lower their exposure to harmful chemicals. The trial enrolls 250 daily smokers who have tried to quit before but aren't ready to quit now. Participants either get e-cigarettes alone or e-cigarettes plus up to 10 coaching sessions over 8 weeks.

What this could mean

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

Active substance
e-cigarettes (NJOY brand) and behavioral support (SWITCH IT coaching)
What this could lead to
If it works, this could offer a practical way for smokers with mental illness who can't quit to reduce their health risks by switching to e-cigarettes.
What could go wrong
This is an early-stage study with 250 participants, so results may not apply to everyone. E-cigarettes are not risk-free, and long-term effects are still unknown.

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 250 people

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

Started

Oct 2024

Expected to finish

Mar 2028

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

21 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.

Diagnostic Criteria (must have one to be eligible): * Schizophrenia * Bipolar disorder * Major Depressive Disorders * Posttraumatic disorder * Other anxiety disorders Additional Inclusion Criteria: * 21 years or older; * English-speaking; * Daily smoker (at least 10 cigarettes/day); * At least one quit attempt in the past 5 years using evidence- based pharmacotherapy or behavioral cessation support; * Not currently interested in quitting. Exclusion Criteria: * Currently residing in a nursing home; * Current diagnosis of Asthma; * Cognitive impairment (score \<26 on the Telephone Interview for Cognitive Status (TICS); * Current use of e-cigarettes (\>once a week); * Psychiatric instability (hospitalized in the past month); * Current AND moderate to severe substance use disorder; * Pregnant or planning to become pregnant; * Use of any smoked products other than cigarettes; * Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer); * Participation in SWITCH IT pilot study.

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Conditions

The condition(s) this trial relates to.

anxiety disorder bipolar disorder Harm Reduction major depressive disorder nicotine dependence post-traumatic stress disorder schizophrenia Vaping

As listed by the trial registrant

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

Tobacco dependence

How to take part

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

  1. The places running it

    2 sites. 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

  • Seven Counties Services

    RECRUITING

    Louisville, Kentucky, 40203, United States

  • The Providence Center

    RECRUITING

    Providence, Rhode Island, 02903, United States

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