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New program aims to help american indians quit smoking

NCT ID NCT04931810

Disease control Sponsor: Lehigh University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tests a smoking cessation program called All Nations Breath of Life, designed specifically for American Indian communities. It involves 576 participants at four sites—two on reservations and two in urban areas. The program includes counseling and support, and success is measured by self-report and breath carbon monoxide levels over six months.

What this could mean

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

Active substance
All Nations Breath of Life (behavioral smoking cessation program)
What this could lead to
If successful, this could provide an effective, culturally tailored program to help American Indians quit smoking, reducing smoking-related diseases in these communities.
What could go wrong
This is an implementation trial, not a new treatment. Success depends on community engagement and self-reporting, which may limit reliability. The program has shown promise but may not work equally well in all settings.

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 576 people

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

Started

Apr 2021

Expected to finish

Jan 2027

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Self-identified American Indian or allowed to enroll by community site * Age 18 or older * Smokes at least one cigarette per day * Planning to quit smoking * Have a home address and telephone number * Willing to be followed for 6 months * Willing to participate Exclusion Criteria: \- Any of the above do not apply

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Cessation

As listed by the trial registrant

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

Smoking cessation

Contacts and locations

Locations

  • Lehigh University

    Bethlehem, Pennsylvania, 18015, United States

More trials for these conditions

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