Therapy and Peer Support for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byDavid S. Festinger, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Philadelphia College of Osteopathic Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 with opioid use disorder who are eligible and agree to buprenorphine treatment. They must be stable enough not to need inpatient care, able to give informed consent, and provide contact information. People intoxicated, cognitively impaired or psychiatrically unstable at the start are excluded but can join later if conditions improve.

Inclusion Criteria

Permit the research team to use and disclose their protected health information (PHI)

I am approved for buprenorphine treatment for opioid use disorder and agree to follow it.

I am 18 years old or older.

+2 more

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.

Participant Groups

The study tests different psychosocial treatments alongside medication-assisted treatment (MAT) for opioid addiction. It aims to find out which psychosocial approaches work best for various patients rather than using a standard method for all.

4Treatment groups

Active Control

Group I: Treatment as usualActive Control1 Intervention

Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.

Group II: Office based CBTActive Control1 Intervention

Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.

Group III: CRS/CPSActive Control1 Intervention

Those randomized to certified recovery specialist(CRS)/peer support specialist(CPS) will receive a CRS/CPS along with standard treatment from the FQHC.

Group IV: CBT+CRS/CPSActive Control1 Intervention

Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.