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

Public Health Management Corporation

Status: Withdrawn

Conditions: Opioid-use Disorder; Substance Use Disorders

Treatments: Behavioral: Individual Therapy Sessions; Behavioral: Contingency Management; Behavioral: Cognitive Behavioral Therapy (CBT); Behavioral: Peer Recovery Specialist Support; Behavioral: Medication-Assisted Treatment; Behavioral: Psychiatric Consultation; Behavioral: Group Therapy Sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03367234

PCS-1605-35373

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Personalized Addiction-to-Health (PATH)

Experimental group

Description:

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.

Treatment:

Behavioral: Psychiatric Consultation

Behavioral: Medication-Assisted Treatment

Behavioral: Cognitive Behavioral Therapy (CBT)

Behavioral: Individual Therapy Sessions

Behavioral: Contingency Management

Behavioral: Peer Recovery Specialist Support

Standard Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Group Therapy Sessions

Behavioral: Psychiatric Consultation

Behavioral: Medication-Assisted Treatment

Behavioral: Individual Therapy Sessions

Behavioral: Peer Recovery Specialist Support