Phone-Based nurse care shows promise for opioid and depression patients
NCT ID NCT05122676
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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805 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Feb 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Indiana University Health
Indianapolis, Indiana, 46202, United States
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Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
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