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Treatment of Opioid Use: Medication Adherence Therapy

NCT03567356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-04-09

No results posted yet for this study

Summary

To test the feasibility and acceptability of a novel approach for improving the delivery and effectiveness of XRNTX treatment for opioid use disorder (OUD) - the MAT-PLUS intervention. The components of the MAT-PLUS intervention are: XRNTX, initiated during an episode of inpatient/residential treatment and dosed monthly, provides opioid receptor blockade, relapse prevention and overdose prevention; Significant other engagement empowers family members or other designated concerned others, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; Assertive outreach incorporates frequent multi-channel outreach, in a model that specifically targets engagement and motivation for medication adherence; Counselor care coordination and case management focused on medication management and adherence. This objective #1 will be accomplished by conducting a small-scale, 2-arm, open label, RCT pilot study of 4 months of treatment with the MAT-PLUS intervention (significant other engagement and training, medication care coordination by counselors, assertive outreach) + TAU (monthly doses of XRNTX + routine counseling), vs TAU for n=40 (20 per arm) patients with OUD. Adult patients ages 18+ who receive an initial dose of XRNTX during an index episode of inpatient/residential/detox treatment for opioid addiction at a public-sector community treatment program treatment, with intention to continue in outpatient treatment. The experimental arm will receive the MAT-PLUS intervention for 4 months of ongoing outpatient treatment with XRNTX. The control arm will receive 4 months of standard TAU (XRNTX + clinic-based counseling) without MAT-PLUS. At the beginning of the trial an additional small (N = 4 or 5) group of test patients will receive the MAT-PLUS intervention to test and refine the study procedures.

Conditions

  • Opioid Dependence
  • Opioid-Related Disorders

Interventions

OTHER

MAT-PLUS "Helping Hands"

1\) Significant other engagement through the "Helping Hands" approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing.

Sponsors & Collaborators

  • Potomac Health Foundations

    lead OTHER

Principal Investigators

  • Marc Fishman, MD · Maryland Treatment Centers/PHF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567356 on ClinicalTrials.gov