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

Not Applicable

Withdrawn

• Conditions: Substance Use Disorders; Opioid-use Disorder

• Registration Number: NCT03367234
• Lead Sponsor: Public Health Management Corporation

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.

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 Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21
• Study Start: 2019-07
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in confirmed substance abstinence	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.
Change in retention in treatment	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

Name	Time	Method
Lower rates of service utilization	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
Higher quality of life	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
Lower rates of HIV risk behaviors	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.