Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients

Opioid-use Disorder Clinical Trial

Official title:

Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04650386
• Other study ID #: 1908
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	PHMC Care Clinic	Philadelphia	Pennsylvania
United States	Project HOME Stephen J. Klein Wellness Center	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Public Health Management Corporation	Philadelphia College of Osteopathic Medicine, University of Pennsylvania

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis-confirmed abstinence from opioids at 3 month follow up	Participants will provide a urine specimen at the 3 month follow up assessment. 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.	3 months post study entry
Primary	Urinalysis-confirmed abstinence from opioids at 6 month follow up	Participants will provide a urine specimen at the 6 month follow up assessment. 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.	6 months post study entry
Primary	Urinalysis-confirmed abstinence from opioids at 9 month follow up	Participants will provide a urine specimen at the 9 month follow up assessment. 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.	9 months post study entry
Primary	Urinalysis-confirmed abstinence from opioids at 12 month follow up	Participants will provide a urine specimen at the 12 month follow up assessment. 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 MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.	12 months post study entry
Secondary	Abstinence from or reductions in use of other (non-opioid) psychoactive substances	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
Secondary	Retention in buprenorphine-based OBOT	Including appointment attendance, medication and treatment adherence, and retention in and completion of treatment.	Through 12 months post-study entry
Secondary	Quality of life assessment	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.	Through 12 months post-study entry
Secondary	Psychosocial functioning/Multidimensional problem severity	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.	Through 12 months post-study entry
Secondary	Treatment satisfaction	Treatment satisfaction will be measured using a modified version of the Treatment Services Review (TSR). The TSR measures patient therapeutic engagement in and satisfaction with treatment.	Through 12 months post-study entry