CompletedNot Applicable

The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions

United States567 participantsStarted 2020-12-15

Plain-language summary

Collaborative care for mental health is increasingly common, but most primary care practices have not embraced similar models for opioid use disorder (OUD). This study will refine and test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety or post-traumatic stress disorder (PTSD) in primary care. We also will examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years and older;
. a diagnosis of opioid use disorder using DSM-5 criteria within the last 12 months OR have taken medication for opioid use disorder (MOUD) within the last 12 months;
. agree to receive medication for opioid use disorder at the primary care site (the first line pharmacotherapy is buprenorphine-naloxone and the second line pharmacotherapy will include extended-release injectable naltrexone);
. meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD;
. able to communicate in English; and
. willing to give informed consent.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in opioid use based on self-reported

Timeframe: Baseline and monthly for 6 months

Change in opioid use based on toxicology

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Depression

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Anxiety

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Post-traumatic Stress Disorder

Timeframe: Baseline and monthly for 6 months

Trial details

NCT IDNCT04245423

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-28

View on ClinicalTrials.gov More Opioid-use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18 years and older;
. a diagnosis of opioid use disorder using DSM-5 criteria within the last 12 months OR have taken medication for opioid use disorder (MOUD) within the last 12 months;
. agree to receive medication for opioid use disorder at the primary care site (the first line pharmacotherapy is buprenorphine-naloxone and the second line pharmacotherapy will include extended-release injectable naltrexone);
. meet criteria for depression, anxiety (panic disorder, social anxiety disorder, obsessive-compulsive disorder, or generalized anxiety disorder), or PTSD;
. able to communicate in English; and
. willing to give informed consent.

Exclusion criteria

What they're measuring

Change in opioid use based on self-reported

Timeframe: Baseline and monthly for 6 months

Change in opioid use based on toxicology

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Depression

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Anxiety

Timeframe: Baseline and monthly for 6 months

Change in psychiatric symptoms - Post-traumatic Stress Disorder

Timeframe: Baseline and monthly for 6 months