Opioid-use Disorder Clinical Trial
Official title:
The Whole Health Study: Collaborative Care for OUD and Mental Health Conditions
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.
This research aims to refine and rigorously test a collaborative care model for patients with opioid use disorder (OUD) and depression, anxiety disorder, or post-traumatic stress disorder (PTSD) in primary care. The investigators will also examine clinician and practice characteristics associated with successful implementation and the cost effectiveness of different care models. The primary aims of this proposal are: (1) Rapidly prototype and test our collaborative care models to optimize them for implementation at the University of Pennsylvania Health System (UPHS) primary care clinics for the treatment of individuals with co-occurring mental health problems and opioid use disorder (OUD); (2) Conduct a randomized clinical trial (RCT) among 1,185 primary care patients aged 18 years and older with OUD and depression, anxiety or PTSD. Patients will be randomized to one of three conditions: a) Augmented Usual Care (AUC), which consists of a primary care physician (PCP) waivered to prescribe buprenorphine, a mental health care manager, and an addiction psychiatrist to consult on Medication-Assisted Treatment (MAT); b) Collaborative Care (CC), which consists of a waivered PCP, a mental health care manager who receives OUD training, and a psychiatrist who provides telephonic consultation for OUD and mental health; or c) Collaborative Care Plus (CC+), which consists of all the elements of CC, plus a Certified Recovery Specialist (CRS) to help with patient engagement in treatment and retention in care; (3) Measure clinician- level factors associated with implementation of each component and metrics of fidelity and reach, our primary implementation outcomes of interest; and (4) Assess the costs to primary care practices of implementing and delivering AUC, CC and CC+ and the change in total healthcare costs associated with the implementation. Successful completion of the proposed study will provide definitive evidence regarding the most parsimonious set of elements of integrated collaborative care required to maximize outcomes for individuals with OUD and psychiatric disorders. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Completed |
NCT04505540 -
Start Treatment and Recovery for Opioid Use Disorder
|
N/A | |
Completed |
NCT03065049 -
Transforming Recovery Through Exercise and Community
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Suspended |
NCT05001789 -
Cognitive Functioning in Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04650386 -
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
|
N/A | |
Completed |
NCT03715634 -
Study of a Novel Subcutaneous Depot Formulation of Buprenorphine
|
Phase 1 | |
Enrolling by invitation |
NCT04991974 -
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine
|
Phase 2/Phase 3 | |
Completed |
NCT04122755 -
Single Ascending Dose Study of ALA-1000
|
Phase 1 | |
Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
Recruiting |
NCT05049460 -
Adjunctive Transcranial Stimulation to Reduce Impulsivity in Opiate Use Disorder
|
N/A | |
Recruiting |
NCT05028998 -
COVID-19-Related Opioid Treatment Policy Evaluation
|
||
Completed |
NCT05047627 -
Digital Intervention to Treat Anxiety and Depression Among Persons Receiving Treatment for Opioid Use Disorder
|
N/A | |
Active, not recruiting |
NCT04129580 -
reSET-O RCT (Randomized Controlled Trial)
|
N/A | |
Recruiting |
NCT03923374 -
Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes
|
||
Completed |
NCT04464421 -
SMART Effectiveness Trial
|
N/A | |
Completed |
NCT04056182 -
Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment
|
Phase 2 | |
Suspended |
NCT02687360 -
Imaging the Effects of rTMS on Chronic Pain
|
N/A |