Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients

NCT ID: NCT04650386

Last Updated: 2024-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2024-05-31

Brief Summary

The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.

Detailed Description

This study will help to inform best practices for providing psychosocial treatment within the context of office-based opioid treatment (OBOT) with buprenorphine. We will use a staged approach to develop and evaluate an adaptive approach to the provision of adjunctive psychosocial treatment that includes medication management by a buprenorphine provider and linkage to CRSs and CBT depending on the needs of the patient. The specific aims of the proposal are listed below.

Aim 1: Work collaboratively with our multidisciplinary team to develop specific protocols for the CRS and CBT interventions and establish algorithms based on behavioral criteria to determine when each intervention should be implemented. As a part of this aim, we will also develop standard procedures for delivering each intervention and train interventionists [i.e., CRSs and Licensed Professional Counselors (LPCs)] to deliver them with fidelity.

Aim 2: Conduct a two-group randomized study to evaluate the efficacy of the adaptive intervention relative to TAU. Outcomes to be examined will include urinalysis-confirmed opioid use, retention in buprenorphine- based OBOT, quality of life, and psychosocial functioning through one year post-study entry.

Aim 3: Conduct a qualitative evaluation of the intervention and develop a strategic plan for its dissemination. We will conduct focus groups with clinic staff and relevant stakeholders to determine the utility and acceptability of the adaptive intervention. In addition, we will hold an expert roundtable to identify mechanisms for increasing sustainability and enhancing adoption by other office-based buprenorphine programs to inform the development of the strategic plan.

Aim 4: Establish a training program in clinical research for minority students. Eight undergraduate students from a historically minority higher education institution will be selected to participate in 9-month internships during which they will receive comprehensive and pragmatic training in the full range of clinical research from study design to dissemination.

Conditions

Opioid-use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment As Usual (TAU)

Participants assigned to the TAU condition will be scheduled for buprenorphine medication management appointments and will receive OBOT at the FQHC and adjunctive psychosocial treatment as typically provided at the FQHC. The team will continue to meet with the patient during subsequent MAT visits on a decreasing frequency, with some slight site-specific variation. The schedule of MAT visits generally includes 3 clinic visits during the week of induction, 1-2 visits per week until the patient is stabilized, and monthly thereafter. Behavioral health clinicians provide support to the patient, discuss UDS results, assist with strategic problem-solving around recovery and adjustment to sobriety, and monitor the patient's engagement in MAT.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Adaptive Intervention

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Group Type: EXPERIMENTAL

Psychosocial support determined by adaptive treatment algorithm

Intervention Type: BEHAVIORAL

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Interventions

Psychosocial support determined by adaptive treatment algorithm

Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Have initiated office-based buprenorphine treatment for OUD at the FQHC within the last 4 weeks;
• Not require an inpatient level of care as determined by the healthcare provider; and
• Be capable of providing valid contact information and informed consent.

Exclusion Criteria

• Patient is under the age of 18;
• Co-morbid psychiatric disorder indicating the need for more intensive residential treatment
• Patient is unable to provide informed consent.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philadelphia College of Osteopathic Medicine

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Public Health Management Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Dugosh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

PHMC

Locations

Project HOME Stephen J. Klein Wellness Center

Philadelphia, Pennsylvania, United States

PHMC Care Clinic

Philadelphia, Pennsylvania, United States

Countries

United States

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Other Identifiers

1908

Identifier Type: -

Identifier Source: org_study_id