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App aims to help mentally ill kick the habit

NCT ID NCT05030272

Disease control Sponsor: Wake Forest University Health Sciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a smartphone app designed for people with serious mental illness can help them quit smoking better than standard methods. Researchers enrolled 343 adults with conditions like bipolar disorder or schizophrenia who wanted to quit. Participants used either the special app or usual care, and success was measured by not smoking for at least 7 days after 6 months.

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

343 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2025

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: 1. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder 2. Functional impairment as indicated by a score of 2 or greater on the WHODAS 8 item version 3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months; 4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months; 5. Age 18 and older; 6. Willing and medically eligible to use NRT; 7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.). Exclusion Criteria 1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year. 2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998); 3. Being pregnant or the intention to become pregnant in the next 6 months; 4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation; 5. Currently using e-cigarettes or other tobacco products besides cigarettes \> 10 days in the past 30 days. 6. Unsafe to participate in the study due to moderate or high risk of suicide determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) - Screen Version, defined as answering 'yes' to both question 3 for the last month and 'yes' to question 6 for lifetime (moderate risk), or 'yes' to questions 4 and 5 for the recent month, or 'yes' to question 6 for the last 3 months (high risk).

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Conditions

The condition(s) this trial relates to.

bipolar disorder dysthymic disorder major depressive disorder nicotine dependence psychiatric disorder Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

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

Bipolar disorder Mental illness Persistent depressive disorder Recurring major depressive disorder Schizoaffective disorder Schizophrenia Tobacco use disorder

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27705, United States

  • University at Buffalo

    Buffalo, New York, 14260-1660, United States

  • Wake Forest Health Sciences

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.