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

August 1, 2025 updated by: Public Health Management Corporation

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, 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: David S Festinger, Ph.D.
  • Phone Number: 215-871-6546
  • Email: DavidFe@pcom.edu

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19131
        • Philadelphia College of Osteopathic Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MAT- OBOT
Those randomized to MAT standard of care will continue to receive standard office-based buprenorphine treatment.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Active Comparator: MAT+ office-based CBT
Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with office-based CBT.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Active Comparator: MAT+ CRS/Peer Support Specialist
Those randomized to MAT+ office-based CBT will receive office-based buprenorphine treatment along with a CRS.
Behavioral: Psychosocial treatment
Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
Active Comparator: MAT+ both CBT and CRS/Peer Support Specialist
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in urinalysis-confirmed opioid use from baseline through one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
Participants will provide a urine specimen at baseline and 3, 6, 9, and 12-month assessments. Investigators 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
At baseline and 3,6,9, 12-month assessments

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days Retained in Office-Based Buprenorphine Treatment
Time Frame: Through 12 months
Information from the electronic health record (EHR) will be used to determine the number of days of engagement in OBOT. Investigators 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
Changes in quality of life assessment: Short Form-36 (SF-36) from baseline through one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
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. For each subscale, scores may range from 0 to 100 with higher scores reflecting greater quality of life.
At baseline and 3,6,9, 12-month assessments
Changes in multidimensional problem severity from baseline through one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
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. Scores may range from 0 to 1 with higher scores indicating greater problem severity.
At baseline and 3,6,9, 12-month assessments
Changes in the percentage of individuals engaging in urinalysis-confirmed use of other (non-opioid) drugs from baseline to one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
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. A binary variable reflecting other drug use versus no other drug use will be generated for this outcome.
At baseline and 3,6,9, 12-month assessments
Changes in ED utilization from baseline to one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
The ASI-Lite (see above) captures the number of ED visits that the patient experienced during the given timeframe (i.e., past 90 days).
At baseline and 3,6,9, 12-month assessments
Changes in opioid overdose rates
Time Frame: At baseline and 3,6,9, 12-month assessments
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.
At baseline and 3,6,9, 12-month assessments
Changes in treatment satisfaction from baseline to one year post-study entry
Time Frame: At baseline and 3,6,9, 12-month assessments
Treatment satisfaction will be measured using a subscale from the Client Satisfaction Questionnaire-8 (19). The CSQ-8 measures patient therapeutic engagement in and satisfaction with treatment. Scores may range from 8 to 32 with higher scores indicating greater treatment satisfaction.
At baseline and 3,6,9, 12-month assessments

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Job satisfaction and stress
Time Frame: 12 months following the end of recruitment
Investigators 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.
12 months following the end of recruitment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Public Health Management Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
Boston University
University of Pennsylvania
Philadelphia College of Osteopathic Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David S Festinger, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

Yes

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.

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