Collaboration Leading to Addiction Treatment and Recovery From Other Stresses

  • End date
    Jan 29, 2024
  • participants needed
  • sponsor
Updated on 29 January 2021


Collaboration Leading to Addiction Treatment and Recovery from Other Stresses (CLARO) is a five-year project that tests whether delivering care using a collaborative model helps patients with both opioid use disorders and mental health disorders.


Untreated mental illness and substance use disorders are prevalent and can have devastating consequences for the individual, their families and the community. Co-occurring opioid use disorders (OUD) with either depressive disorders and/or post-traumatic stress disorder (PTSD) are of particular concern, because depression and PTSD are prevalent in people with OUD, co-occurring mental illness is linked to an increased risk for opioid misuse and overdose, and because of the high prevalence of the chronic use of prescription opioids in individuals with mental illness, a risk factor for heroin use and the development of an OUD. Primary care is an important and underutilized setting in which to provide treatment for all three disorders, because OUD, depression and PTSD are frequently co-morbid with medical conditions. However, despite the effectiveness of treatments for all three disorders, many individuals never receive treatment; and, when treatment is provided, quality is low. With the rising number of opioid-related fatalities, this is a critical treatment and quality gap in a vulnerable and stigmatized population. Collaborative care (CC) has never been tested with co-occurring disorders (COD), despite research by our team suggesting it may be effective. CC consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our CC model for COD (CC-COD), the CC team also includes a behavioral health psychotherapist (BHP); the evidence-based treatments supported include medications for OUD (MOUD), pharmacotherapy for depression and PTSD, motivational interviewing (MI), problem solving therapy (PST) and Written Exposure Therapy (WET).

The current study consists of a multi-site, randomized pragmatic trial in 13 rural and urban primary care clinics located in Health Professional Shortage Areas (HPSA) of New Mexico to adapt, harmonize and then test whether CCCOD improves access, quality and outcomes for primary care patients with co-morbid OUD and depression and/or PTSD. The study will randomize 900 patients with co-occurring OUD and depression disorder and/or PTSD to receive either CC-COD or enhanced usual care (EUC).

Condition Addiction, Endogenous depression, Depression, Post-Traumatic Stress Disorder, Depression (Major/Severe), Opioid Use Disorder, Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Post-Traumatic Stress Disorders, Depression (Treatment-Resistant), Depressed, Addictions, depressive disorder, PTSD, addictive behaviors, depressed mood, miserable, depressive disorders
Treatment Collaborative care
Clinical Study IdentifierNCT04559893
Last Modified on29 January 2021


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: depressed mood or addictive behaviors or Depressed or Addictions or Post-Traumatic Stress Disorders or Depression (Adolescent) or Depression (Pediatri...?
and older
Receiving primary care at one of the 11 clinical sites
Has OUD and one or more specific co-occurring behavioral health disorders (depression and PTSD)

Exclusion Criteria

Under 18
Does not speak English or Spanish
Unable to consent
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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