Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings

• ClinicalTrials.gov Identifier: NCT03367234
• Recruitment Status: Withdrawn
• First Posted: December 8, 2017
• Last Update Posted: June 21, 2019
• Sponsor: Public Health Management Corporation
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Public Health Management Corporation

Study Description

Brief Summary:

This study evaluates the effectiveness of integrating empirically-supported treatments for an opioid use disorder into a primary care setting. These treatments will include ASAM Criteria multidimensional assessment, cognitive behavioral therapy and relapse prevention with contingency management, medication-assisted treatment, and recovery support services. Half of participants will be assigned to opioid use disorder treatment in a federally qualified health center, and half will receive treatment at a publicly-funded intensive outpatient addiction treatment program which has the ability to offer medication-assisted treatment.

Condition or disease	Intervention/treatment	Phase
Opioid-use Disorder; Substance Use Disorders	Behavioral: Individual Therapy Sessions; Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Medication-Assisted Treatment; Behavioral: Peer Recovery Specialist Support; Behavioral: Group Therapy Sessions; Behavioral: Psychiatric Consultation; Behavioral: Contingency Management	Not Applicable

Detailed Description:

This is a large, simple, comparative effectiveness trial of the Personalized Addiction Treatment-to-Health Model vs. standard care in the community specialty addiction treatment system. PATH combines several empirically supported treatment methods in a flexible schedule in tandem with primary care, with the goals of higher rates of confirmed substance abstinence and treatment retention.

PATH components include: 1) The CONTINUUM multidimensional assessment, an evidence-based implementation of the American Society of Addiction Medicine (ASAM) placement criteria; 2) Cognitive Behavioral Relapse Prevention (CB/RP), a skills-based approach centered on teaching coping skills to handle risky situations that can be practiced and learned; 3) Contingency management (CM), which targets chronic substance use's diminution of brain dopaminergic reward by specifically conditioning positive recovery behaviors via immediate financial incentives; and 4) Recovery Support Services, non-professional community-based services for wrap-around care needs.

Effect sizes for a combined CB/RP and CM approach appear to be large and there is evidence that this combination results in longer lasting improvements presumably as homeostasis returns to the reward system. An extensive literature demonstrates that counseling plus medication-assisted treatment (MAT) yields superior outcomes versus counseling alone. Buprenorphine and extended-release naltrexone are well suited for use in primary care. Buprenorphine is a partial agonist at the mu-opioid receptor that provides anti-withdrawal and anti-craving effects for up to 36 hours on a single dose. Partial agonism and a slow onset diminish the patient's perception of euphoria, limiting abuse, while the long half-life and binding duration make it useful for both detoxification and long-term opioid maintenance. Extended-release naltrexone is a once-monthly intramuscular injection that, following detoxification, provides opioid receptor blockade for at least 30 days and is safe and effective for prolonging abstinence and preventing relapse from opiates.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
• Estimated Study Start Date: July 2019
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Personalized Addiction-to-Health (PATH); Cognitive Behavioral Therapy (CBT) sessions with a behavioral health consultant twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed weeks 27-52; Contingency management rewards for specified recovery behaviors which could include medication adherence, attendance at CB/RP sessions and/or CB/RP exercise participation; Medication-assisted treatment, either extended-release naltrexone once monthly or buprenorphine once daily; Peer recovery specialist support twice weekly for weeks 1-13, once weekly for weeks 14-26, as needed for weeks 27-52; Psychiatric consultation as needed.	Behavioral: Individual Therapy Sessions; One-on-one sessions with a counselor; Behavioral: Cognitive Behavioral Therapy (CBT); Cognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC); Other Names: CBT; CB/RP; Behavioral: Medication-Assisted Treatment; Buprenorphine or Extended-Release Naltrexone; Other Name: MAT; Behavioral: Peer Recovery Specialist Support; Individual and/or group sessions with a certified peer recovery specialist; Behavioral: Psychiatric Consultation; Access to psychiatric consultation; Behavioral: Contingency Management; Rewards for engagement in specified recovery behaviors
Active Comparator: Standard Care; Treatment may differ slightly by treatment program, but addiction specialty Intensive Outpatient Treatment (ASAM Level 2.1) will generally include individual therapy sessions with a counselor 1 hour per week for week; Medication-assisted treatment, either extended-release naltrexone once monthly or suboxone once daily; Group therapy sessions 9 hours per week then decreasing to 3 hours per week; Psychiatric consultation as needed.	Behavioral: Individual Therapy Sessions; One-on-one sessions with a counselor; Behavioral: Medication-Assisted Treatment; Buprenorphine or Extended-Release Naltrexone; Other Name: MAT; Behavioral: Peer Recovery Specialist Support; Individual and/or group sessions with a certified peer recovery specialist; Behavioral: Group Therapy Sessions; Group therapy sessions; Behavioral: Psychiatric Consultation; Access to psychiatric consultation

Outcome Measures

Primary Outcome Measures :

1. Change in confirmed substance abstinence [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   On-site urine drug testing kits rapidly test for cocaine, opiates, amphetamines, methamphetamines, benzodiazepines, cannabis, barbiturates, Phencyclidine, and alcohol. Urine testing will be administered at all follow-ups to capture use within the last 3 days.
2. Change in retention in treatment [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   Verify patient self-report of treatment engagement by acquiring payment data from funders. Federally Qualified Health Centers and Standard Care Intensive Outpatient programs will release study patient records to resolve inconsistencies between patient report and billing data, including treatment session attendance, medications prescribed, prescriptions filled, doses received, and results from urinalysis testing. Data will be collected for the past 3 months.

Secondary Outcome Measures :

1. Lower rates of service utilization [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   Patient reported service utilization including substance abuse treatment, medical services, visits to medical offices, hospitalizations, and emergency room visits received that were not a part of the assigned treatment during the past 3 months
2. Higher quality of life [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   Self-reported enjoyment and satisfaction experienced in various areas of daily functioning during the past week
3. Lower rates of HIV risk behaviors [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   Self-reported drug use, injection-related risk behavior, sexual risk, and HIV testing history and results for the past 3 months.

Other Outcome Measures:

1. Change in Employment Severity Score [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   The American Society of Addiction Medicine (ASAM) Continuum is computer-guided, standardized interview for assessing and caring for patients with substance use disorders and co-occurring conditions. The employment section asks participants about their employment status during the past 3 months using questions from the Addiction Severity Index (ASI). The composite score of the ASI employment section ranges from 0-1 with higher scores indicating greater problem severity.
2. Change in Family/Social Functioning Severity Score [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   The American Society of Addiction Medicine (ASAM) Continuum is computer-guided, standardized interview for assessing and caring for patients with substance use disorders and co-occurring conditions. The family and social functioning section asks participants about their family and social functioning during the past 3 months using questions from the Addiction Severity Index (ASI). The composite score of the ASI family and social functioning section ranges from 0-1 with higher scores indicating greater problem severity.
3. Change in Psychiatric Severity Score [ Time Frame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups ]
   The American Society of Addiction Medicine (ASAM) Continuum is computer-guided, standardized interview for assessing and caring for patients with substance use disorders and co-occurring conditions. The psychiatric section asks participants about their psychiatric functioning during the past 3 months using questions from the Addiction Severity Index (ASI). The composite score of the ASI psychiatric section ranges from 0-1 with higher scores indicating greater problem severity.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patient is 18 years or older
2. As determined according to the ASAM Criteria CONTINUUM Software decision engine, patient meets criteria for: a) Level 1 care, i.e., outpatient treatment, OR b) Level 2 care, i.e., intensive outpatient treatment.

Exclusion Criteria:

1. The medical practitioner or BHC overrule these criteria because medical and psychiatric complications exist that would contraindicate research participation
2. Patient requires an ASAM level of care greater than Level 2
3. The patient reports plans to leave the area (i.e. Philadelphia or Washington, DC greater metropolitan area) within the next 6 months
4. The patient is not English-speaking
5. The patient is unable to provide valid informed consent by correctly describing the key components of consent to the Research Assistant.

Contacts and Locations

Sponsors and Collaborators

Public Health Management Corporation

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: David R Gastfriend, MD; Public Health Management Corporation

  Study Documents (Full-Text)

Documents provided by Public Health Management Corporation:

Study Protocol  [PDF] June 27, 2017

Statistical Analysis Plan  [PDF] November 21, 2017

More Information

• Responsible Party: Public Health Management Corporation
• ClinicalTrials.gov Identifier: NCT03367234
• Other Study ID Numbers: PCS-1605-35373
• First Posted: December 8, 2017
• Last Update Posted: June 21, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Public Health Management Corporation:

Federally Qualified Health Center; Contingency Management; Cognitive Behavioral Therapy; Cognitive Behavioral / Relapse Prevention; Medication Assisted Treatment; Behavioral Health Consultant; Integrated Care

Additional relevant MeSH terms:

Disease; Substance-Related Disorders; Opioid-Related Disorders; Pathologic Processes; Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders