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Phone-Based nurse care shows promise for opioid and depression patients

NCT ID NCT05122676

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a 12-month telephone-based nurse care program for 805 adults with depression and signs of opioid use disorder. Participants were randomly assigned to receive nurse support or usual care. The goal was to see if the program could improve treatment for opioid use and reduce depressive symptoms.

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

805 people

The number who actually took part.

Started

Nov 2021

Finished

Feb 2026

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 Eligible patients must meet all 4 criteria: 1. ≥1 in person or virtual encounter in a primary care setting in the 365 days prior to the data extraction date (pull date); 2. Age ≥18 years at the pull date; 3. ≥1 PHQ-9 depression screening score of ≥10 within the 7 days prior to the pull date. 4. Evidence of potential OUD in the 365 days prior to and including the date of the qualifying PHQ-9 score. Any 1 of the following qualifies as evidence of potential OUD: 1. ≥1 active OUD ICD-10 diagnosis code in any setting except labs; 2. ≥1 prescription (orders or dispensed) for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant); 3. ≥1 procedure code for buprenorphine (oral formulations indicated for OUD, extended release injectable, and implant); 4. ≥1 ICD-10 codes for opioid overdose; 5. ≥1 OUD ICD-10 code, including remission, and prescription (orders or dispensed) or procedure code for injectable naltrexone. EXCLUSION CRITERIA Patients are ineligible who meet any of the criteria below: 1. The only indication of OUD or only PHQ available to determine eligibility came from data protected under 42 CFR Part 2; 2. The patient has already been randomized to the trial or was outreached in the pilot study (including outreach to the primary care provider only); 3. English interpreter required (per health system records). 4. Any one of the following conditions in the 2 years prior to and including the date of the qualifying PHQ: 1. Alzheimer's disease or dementia diagnosis, or medication to treat Alzheimer's or dementia. 2. Severe cognitive limitations. 5. Current active treatment for cancer with chemotherapy or radiation therapy in the past 3 months (not including non-melanoma skin cancers). 6. Previously requested to not participate in research studies at the health system; 7. Documentation of hospice care in the 2 years prior to and including the date of the qualifying PHQ score; 8. Patient is actively being outreached for (or is participating in) depression care management (Kaiser Permanente Washington only)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101, United States

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