Clinical trial NCT03367234: Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
Official title: A Simple Large Trial of Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid-use Disorder
Substance Use Disorders
Keywords: Federally Qualified Health Center
Contingency Management
Cognitive Behavioral Therapy
Cognitive Behavioral / Relapse Prevention
Medication Assisted Treatment
Behavioral Health Consultant
Integrated Care
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2017-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in confirmed substance abstinence
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
measure: Change in retention in treatment
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Secondary outcomes:
measure: Lower rates of service utilization
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
measure: Higher quality of life
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
measure: Lower rates of HIV risk behaviors
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Other outcomes:
measure: Change in Employment Severity Score
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
measure: Change in Family/Social Functioning Severity Score
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
measure: Change in Psychiatric Severity Score
timeFrame: Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups
Locations:
Study officials:
affiliation: Public Health Management Corporation
name: David R Gastfriend, MD
role: PRINCIPAL_INVESTIGATOR
References: