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

Substance Use Disorders Clinical Trial

Official title:

A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03367234
• Other study ID #: PCS-1605-35373
• Status: Withdrawn
• Phase: N/A
• Start date: July 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2019
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Opioid-use Disorder
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Individual Therapy Sessions
One-on-one sessions with a counselor
• Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC)
• Medication-Assisted Treatment
Buprenorphine or Extended-Release Naltrexone
• Peer Recovery Specialist Support
Individual and/or group sessions with a certified peer recovery specialist
• Group Therapy Sessions
Group therapy sessions
• Psychiatric Consultation
Access to psychiatric consultation
• Contingency Management
Rewards for engagement in specified recovery behaviors

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Public Health Management Corporation	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Employment Severity Score	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.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Other	Change in Family/Social Functioning Severity Score	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.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Other	Change in Psychiatric Severity Score	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.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Primary	Change in confirmed substance abstinence	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.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Primary	Change in retention in treatment	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.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Secondary	Lower rates of service utilization	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	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Secondary	Higher quality of life	Self-reported enjoyment and satisfaction experienced in various areas of daily functioning during the past week	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Secondary	Lower rates of HIV risk behaviors	Self-reported drug use, injection-related risk behavior, sexual risk, and HIV testing history and results for the past 3 months.	Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups