Patient-Centered Care for Opioid Use Disorders in Federally Qualified Healthcare Centers and Specialty Care Settings
NCT ID: NCT03367234
Last Updated: 2019-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-07-31
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Psychiatric Consultation
Access to psychiatric consultation
Contingency Management
Rewards for engagement in specified recovery behaviors
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.
Individual Therapy Sessions
One-on-one sessions with a counselor
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Public Health Management Corporation
OTHER
Responsible Party
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Principal Investigators
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David R Gastfriend, MD
Role: PRINCIPAL_INVESTIGATOR
Public Health Management Corporation
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PCS-1605-35373
Identifier Type: -
Identifier Source: org_study_id
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