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

NCT03367234 | Withdrawn DMC

• 1 other identifier: PCS-1605-35373
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Lower rates of service utilization

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

• Higher quality of life

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

• Lower rates of HIV risk behaviors

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

Other Outcomes (3)

• Change in Employment Severity Score

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

• Change in Family/Social Functioning Severity Score

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

• Change in Psychiatric Severity Score

  Baseline, 3-, 6-, 9-, 12-, 15-, and 18 month follow-ups

Study Arms (2)

Personalized Addiction-to-Health (PATH)

EXPERIMENTAL

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.

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

Standard Care

ACTIVE COMPARATOR

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.

Behavioral: Individual Therapy Sessions; Behavioral: Medication-Assisted Treatment; Behavioral: Peer Recovery Specialist Support; Behavioral: Group Therapy Sessions; Behavioral: Psychiatric Consultation

Interventions

Individual Therapy Sessions BEHAVIORAL

One-on-one sessions with a counselor

Personalized Addiction-to-Health (PATH); Standard Care

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

Cognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC)

Also known as: CBT, CB/RP

Personalized Addiction-to-Health (PATH)

Medication-Assisted Treatment BEHAVIORAL

Buprenorphine or Extended-Release Naltrexone

Also known as: MAT

Personalized Addiction-to-Health (PATH); Standard Care

Peer Recovery Specialist Support BEHAVIORAL

Individual and/or group sessions with a certified peer recovery specialist

Personalized Addiction-to-Health (PATH); Standard Care

Group Therapy Sessions BEHAVIORAL

Group therapy sessions

Standard Care

Psychiatric Consultation BEHAVIORAL

Access to psychiatric consultation

Personalized Addiction-to-Health (PATH); Standard Care

Contingency Management BEHAVIORAL

Rewards for engagement in specified recovery behaviors

Personalized Addiction-to-Health (PATH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years or older
• 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.

You may not qualify if:

• The medical practitioner or BHC overrule these criteria because medical and psychiatric complications exist that would contraindicate research participation
• Patient requires an ASAM level of care greater than Level 2
• The patient reports plans to leave the area (i.e. Philadelphia or Washington, DC greater metropolitan area) within the next 6 months
• The patient is not English-speaking
• The patient is unable to provide valid informed consent by correctly describing the key components of consent to the Research Assistant.

Sponsors & Collaborators

• Public Health Management Corporation: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy; Opiate Substitution Treatment

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Drug Therapy; Therapeutics

Study Officials

• David R Gastfriend, MD

  Public Health Management Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 8, 2017
• Study Start: July 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share