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 range18 Years

SexALL

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

✕. acutely suicidal and needs immediate hospitalization, manic or psychotic (patients will not be randomized and PI or study physician covering for PI will be notified immediately); and
✕. lack of a phone.

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 range18 Years

SexALL

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

✕. acutely suicidal and needs immediate hospitalization, manic or psychotic (patients will not be randomized and PI or study physician covering for PI will be notified immediately); and
✕. lack of a phone.

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