Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    440
  • sponsor
    Philadelphia College of Osteopathic Medicine
Updated on 26 January 2021
buprenorphine
addiction
narcotic use

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, 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.

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 (CRS's)/ Certified Peer Specialists (CPS's) 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/CPS, and (4) MM with both CBT and CRS/CPS. 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/CPS study arms, CRS's/CPS'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/CPS. 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/CPS.

Details
Condition Opioid Use Disorder
Treatment Psychosocial Treatment
Clinical Study IdentifierNCT04257214
SponsorPhiladelphia College of Osteopathic Medicine
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults (18 years)
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
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