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

June 15, 2023 updated by: Philadelphia College of Osteopathic Medicine

Identifying Optimal Psychosocial Interventions for Patients Receiving Office-Based Buprenorphine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Atlantic City, New Jersey, United States, 08401
        • Recruiting
        • AtlantiCare
        • Contact:
          • Sandra Festa, M.S.W.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Philadelphia FIGHT
        • Contact:
          • Emily Loscalzo, PsyD
      • Philadelphia, Pennsylvania, United States, 19123
        • Active, not recruiting
        • Care Clinic
      • Philadelphia, Pennsylvania, United States, 19130
        • Recruiting
        • Delaware Valley Community Health
        • Contact:
          • Julia DeJoseph, M.D.
      • Philadelphia, Pennsylvania, United States, 19601
        • Active, not recruiting
        • Berks Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Those randomized to treatment as usual will receive standard treatment from one of four FQHC sites.
Active Comparator: Office based CBT
Those randomized to Cognitive Behavioral Treatment will receive cognitive behavioral treatment (CBT) along with standard treatment from the FQHC.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Active Comparator: CRS/CPS
Those randomized to certified recovery specialist(CRS)/peer support specialist(CPS) will receive a CRS/CPS along with standard treatment from the FQHC.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Active Comparator: CBT+CRS/CPS
Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT and a CRS.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinalysis-confirmed opioid use
Time Frame: Through 12 months post-study entry
Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMA. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Through 12 months post-study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention in Office-Based Buprenorphine Treatment
Time Frame: Through 12 months post-study entry
Information from the electronic health record (EHR) will be used to determine engagement in OBOT. We will obtain data from the EHR reflecting OBOT-related data including appointments attended, prescription refill information, and service dates. A patient will be identified as having dropped out of OBOT when 30 days without current buprenorphine prescription or 30 days without meeting with provider have passed.
Through 12 months post-study entry
Quality of life assessment
Time Frame: Through 12 months post-study entry
Quality of life will be measured using the Short Form-36 (SF-36). The SF-36 is a self-report inventory that assesses eight dimensions of physical and mental health-related quality of life. The SF-36 has been shown to have high reliability and validity. The SF-36 individual item scores are recoded to values from 0-100. Items in the same scale are then averaged together to create the 8 scale scores. The scales include physical functioning, role limitations die to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. A higher score indicates a more positive outcome in the scale.
Through 12 months post-study entry
Multidimensional problem severity
Time Frame: Through 12 months post-study entry
Multidimensional problem severity, a secondary outcome, will be measured using the Addiction Severity Index-Lite (ASI-Lite). The ASI-Lite is a reliable and valid multidimensional assessment that provides composite scores reflecting current problem severity in the medical, employment, alcohol, drug, legal, family/social, and psychiatric areas. The Addiction Severity Index-Lite yields problem severity scores for the following psychosocial dimensions: drug, alcohol, employment, medical, legal, psychiatric, and family/social. Within each dimension, scores can range from 0 to 1 with higher scores indicating higher problem severity.
Through 12 months post-study entry
Urinalysis-confirmed use from other (non-opioid) drugs
Time Frame: Through 12 months post-study entry
Results from the CLIAwaived® 14-panel test and fentanyl strip described above for the primary outcome will be used as an indicator of this outcome.
Through 12 months post-study entry
ED utilization
Time Frame: Through 12 months post-study entry
The Addiction Severity Index-Lite (ASI-Lite) yields problem severity scores for the following psychosocial dimensions: drug, alcohol, employment, medical, legal, psychiatric, and family/social. Within each dimension, scores can range from 0 to 1 with higher scores indicating higher problem severity. The ASI-Lite captures the number of ED visits that the patient experienced during the given timeframe (i.e., past 90 days).
Through 12 months post-study entry
Opioid overdose rates
Time Frame: Through 12 months post-study entry
The ASI-Lite (see above) captures the number of opioid overdoses that a patient experienced during the given timeframe (i.e., past 90 days). In addition, opioid overdoses will be extracted from the patient's clinical record.
Through 12 months post-study entry
Treatment satisfaction
Time Frame: Through 12 months post-study entry
Treatment satisfaction will be measured using a subscale from the Client Satisfaction Questionnaire-8. The CSQ-8 measures patient therapeutic engagement in and satisfaction with treatment. Individual scores from the 8 items are added and scores can range from 8-32 with a higher score indicating greater satisfaction.
Through 12 months post-study entry

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider outcome: Job satisfaction and stress
Time Frame: Through study completion, an average of 1 year
We will hold focus groups with all key members of the clinical care team at each Federally Qualified Health Center (FQHC) site following completion of the trial to examine their perceptions about how the study interventions impacted their job-related stress and job satisfaction. The discussion will center on how the different interventions, separately or in combination, influenced the providers.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philadelphia College of Osteopathic Medicine

Collaborators

Patient-Centered Outcomes Research Institute
Boston University
University of Pennsylvania
Public Health Management Corporation

Investigators

  • Principal Investigator: Michelle R Lent, Ph.D., Philadelphia College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBOT-2018C2-13158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Opioid Use Disorder

Clinical Trials on Psychosocial treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe