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New study: can a therapy and app ease pain and opioid struggles?

NCT ID NCT05039554

Symptom relief Sponsor: Albert Einstein College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This study tests whether a type of talk therapy called Acceptance and Commitment Therapy (ACT) and a smartphone care management app can help people with both opioid use disorder and chronic pain. About 127 adults already on buprenorphine treatment will try one or both tools. The goal is to see if these approaches reduce pain interference and illicit opioid use.

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

125 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Apr 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

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. 18 years old or older; 2. English or Spanish proficiency; 3. receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and 4. CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed Exclusion Criteria: 1. Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis); 2. psychotropic medication changes within the past three months prior to enrollment; 3. CP related to malignancy; 4. received ACT or similar therapeutic intervention in the past; 5. initiated psychotherapy within the past three months; 6. neurocognitive conditions that may prevent participants from accessing telehealth services; 7. current use of a smartphone health platform similar to the Valera app; 8. are unable or unwilling to provide signed consent for participation

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Conditions

The condition(s) this trial relates to.

Chronic Pain chronic pain syndrome opiate dependence

As listed by the trial registrant

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

Chronic pain Opioid-use disorder

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

More trials for these conditions

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