Clinical trial NCT06359340: Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder
Official title: Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Opioid Use
Buprenorphine
Psychosocial Treatment
Medication Assisted Treatment
Cognitive Behavioral Therapy
Peer Support
Opioid Use Disorder
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Boston University
name: Patient-Centered Outcomes Research Institute
name: Philadelphia College of Osteopathic Medicine
name: University of Pennsylvania
First posted: 2024-04-11
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Current clinical guidelines for medication assisted treatment (MAT) of opioid use disorder (OUD) recommend that treatment include a psychosocial component to help address psychological factors related to addiction. However, a knowledge gap exists regarding the most effective forms of psychosocial intervention and what interventions are most effective for different types of patients. This gap represents a significant barrier to the widespread implementation of effective office-based opioid treatment (OBOT) with buprenorphine, which is important to improving opioid treatment and responding to the critical needs of individuals living with OUD. The overarching goal of this patient-centered research is to address the diverse needs and preferences of OUD patients in regards to psychosocial approaches and to overcome the "one-size-fits-all" strategies that are typically used to treat OUD. Importantly, the investigators arrived at this goal, in part, through collaboration and consultation with former patients who have received different types of treatments for OUD. In this manner, patients provided important insight to inform the selection of interventions to be evaluated, patient characteristics that may differentially impact the effects of the interventions, and the patient outcomes to be examined.

Detailed description: The study will evaluate the comparative effectiveness of two psychosocial approaches, Cognitive Behavioral Therapy and peer support through the use of Certified Recovery Specialists provided within the context of office-based buprenorphine treatment. Patients will be randomly assigned to receive either (1) standard Medication Management (MM) as typically provided at the site, (2) MM with office-based CBT, (3) MM with CRS, and (4) MM with both CBT and CRS. In MM, patients will be seen by providers at least weekly until stable, and stabilized patients will then be seen by the provider on a monthly basis. If a patient needs a higher level of care, they will be referred to appropriate specialty treatment to ensure their safety. In the CBT study arms, CBT will be provided through 12 individual manualized sessions scheduled to coincide with patients' MM appointments when possible. As outlined by the National Institute on Drug Abuse (NIDA), sessions will cover standard CBT topics and include exercises and homework. Meta-analyses and reviews have concluded that CBT is an effective treatment across a range of SUDs and has helped to enhance treatment retention, improve medication adherence, and address ancillary problems. In the CRS study arms, CRS's will meet with clients following their first OBOT session to assist them in accessing community resources and overcoming treatment barriers, and provide ongoing patient navigation services to promote attendance at OBOT appointments. These appointments will occur either in-person or over the phone and all meetings will be tracked by the CRS. Studies indicate that peer-delivered services for individuals with mental health disorders are effective in engaging "difficult-to-reach" individuals and improving multidimensional outcomes. In the combined CBT/CRS study arm, clients will receive the individual CBT sessions and be assigned to a CRS.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years)
* Meet DSM 5 criteria for moderate to severe OUD;
* Be deemed eligible for buprenorphine treatment for OUD by the FQHC treatment provider and agree to engage in this treatment;
* Not require an inpatient level of care as determined by the healthcare provider;
* Be capable of providing valid contact information and informed consent; and
* Permit the research team to use and disclose their protected health information (PHI).

Exclusion Criteria:

Individuals who are intoxicated, cognitively impaired, or psychiatrically unstable at baseline will not be included; however, they may subsequently be included if the disqualifying condition subsides.

DSM 5 criteria for OUD include:

* Taking opioids in larger amounts or longer than intended;
* Failed efforts to quit or cut back;
* Spending a lot of time obtaining the opioid;
* Craving or urges to use;
* Repeated inability to carry out major work, school, or home obligations;
* Continued use despite persistent or recurring interpersonal problems worsened by opioid use;
* Stopping or reducing important social, recreational activities due to opioid use;
* Recurrent use of opioids in physically hazardous situations;
* Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance;
* Tolerance; and
* Withdrawal. Moderate OUD severity is denoted by the presence of 4 or 5 of these symptoms and severe OUD is denoted by 6 or more symptoms. Patients will be excluded from the study if their SUD is primarily for a different substance, or their co-morbid psychiatric needs indicate enhanced needs.

Primary outcomes:
measure: Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
Secondary outcomes:
measure: Days Retained in Office-Based Buprenorphine Treatment
timeFrame: Through 12 months
measure: Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
measure: Changes in multidimensional problem severity from baseline through one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
measure: Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
measure: Changes in ED utilization from baseline to one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
measure: Changes in opioid overdose rates
timeFrame: At baseline and 3,6,9, 12-month assessments
measure: Changes in treatment satisfaction from baseline to one year post-study entry
timeFrame: At baseline and 3,6,9, 12-month assessments
Other outcomes:
measure: Job satisfaction and stress
timeFrame: 12 months following the end of recruitment
Locations:
city: Philadelphia
country: United States
facility: Philadelphia College of Osteopathic Medicine
state: Pennsylvania
Study officials:
affiliation: Philadelphia College of Osteopathic Medicine
name: David S Festinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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