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Completed

NCT Number: NCT04650386

Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PHMC Care Clinic, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychosocial support determined by adaptive treatment algorithm

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.

Primary outcomes

  1. Urinalysis-confirmed abstinence from opioids at 3 month follow up

    Time frame: 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.

  2. Urinalysis-confirmed abstinence from opioids at 6 month follow up

    Time frame: 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.

  3. Urinalysis-confirmed abstinence from opioids at 9 month follow up

    Time frame: 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.

  4. Urinalysis-confirmed abstinence from opioids at 12 month follow up

    Time frame: 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 outcomes

  1. Abstinence from or reductions in use of other (non-opioid) psychoactive substances

    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.

  2. Retention in buprenorphine-based OBOT

    Time frame: Through 12 months post-study entry

    Including appointment attendance, medication and treatment adherence, and retention in and completion of treatment.

  3. 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.

  4. Psychosocial functioning/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.

  5. Treatment satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Public Health Management Corporation

Other

Collaborators

  • Philadelphia College of Osteopathic Medicine
  • University of Pennsylvania

Registry information

Official study title

Enhancing Office-based Buprenorphine Treatment: An Adaptive Psychosocial Approach

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2020
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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