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Can a breathing gadget curb addiction cravings?

NCT ID NCT05454657

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a wearable device that guides users through slow, rhythmic breathing to help manage stress and cravings. 120 adults with substance use disorder used the device daily for 8 weeks while continuing their usual treatment. Researchers measured changes in mood, cravings, and substance use to see if the device provides extra support during recovery.

What this could mean

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

Active substance
Heart rate variability biofeedback device
What this could lead to
If it works, this could provide a practical, on-demand tool to help people with substance use disorder reduce cravings and prevent relapse.
What could go wrong
This is a small pilot study with no control group for the device, so results may not be conclusive. The device requires daily practice, and adherence may be low.

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

120 people

The number who actually took part.

Started

Jan 2023

Finished

Jul 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: * ≥18 years of age * Own a smartphone * English proficiency * DSM 5 diagnosis of substance use disorder * In the first year of a current substance use disorder recovery attempt with a goal of total alcohol and other drug abstinence Exclusion Criteria: * Medical history of severe cardiac arrhythmia * Active psychosis

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Conditions

The condition(s) this trial relates to.

substance-related disorder

As listed by the trial registrant

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

Substance use disorders

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114-4714, United States

More trials for these conditions

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