Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients

Sponsor

Public Health Management Corporation (Other)

Overall Status

Recruiting

CT.gov ID

NCT04650386

Collaborator

Philadelphia College of Osteopathic Medicine (Other), Lincoln University (Other), University of Pennsylvania (Other)

250

Enrollment

Locations

Arms

32.3

Anticipated Duration (Months)

125

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder	Behavioral: Psychosocial support determined by adaptive treatment algorithm	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach

Actual Study Start Date :

Sep 21, 2020

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Behavioral: Psychosocial support determined by adaptive treatment algorithm

Outcome Measures

Primary Outcome Measures

Urinalysis-confirmed abstinence from opioids at 3 month follow up [3 months post study entry]
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.
Urinalysis-confirmed abstinence from opioids at 6 month follow up [6 months post study entry]
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.
Urinalysis-confirmed abstinence from opioids at 9 month follow up [9 months post study entry]
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.
Urinalysis-confirmed abstinence from opioids at 12 month follow up [12 months post study entry]
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.

Secondary Outcome Measures

Abstinence from or reductions in use of other (non-opioid) psychoactive substances [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.
Retention in buprenorphine-based OBOT [Through 12 months post-study entry]
Including appointment attendance, medication and treatment adherence, and retention in and completion of treatment.
Quality of life assessment [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.
Psychosocial functioning/Multidimensional problem severity [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.
Treatment satisfaction [Through 12 months post-study entry]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.