Treatment of Opioid Use: Medication Adherence Therapy

NCT03567356 | Completed

• 1 other identifier: MTC002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean number of XRNTX doses within each group

  Mean Number of XRNTX doses received within 4 months of study

  4 months

Secondary Outcomes (3)

• Rate of opioid relapse during the study period

  Data measured every 2 weeks for the duration of the study period

• Percent Linkage to continuing care

  1 month

• Mean Number of days of opioid use

  4 months

Study Arms (2)

Treatment as Usual

NO INTERVENTION

TAU will contain patients who will be receiving treatment for opioid use disorder through their usual venues without the family engagement, assertive outreach, and home delivery of XRNTX doses.

MAT-Plus Intervention

EXPERIMENTAL

The intervention group will receive the multi-component MAT-PLUS treatment: 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.

Other: MAT-PLUS "Helping Hands"

Interventions

MAT-PLUS "Helping Hands" OTHER

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.

MAT-Plus Intervention

Eligibility Criteria

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

You may qualify if:

• Adults age 18+ with OUD who present for an index episode of residential/inpatient opioid detoxification and seek treatment with XRNTX at community treatment provider Mountain Manor Treatment Center (MMTC)

You may not qualify if:

• LFTs \> 5x ULN
• Psychiatric or medical instability (eg suicidality, psychosis. Sickle Cell disease with frequent crises, etc) that would preclude participation in the trial
• Living situation (location greater than 60 miles from the center, homelessness) that that would preclude participation in the trial

Sponsors & Collaborators

• Potomac Health Foundations: lead

Study Sites (1)

Mountain Manor Treatment Center

Baltimore, Maryland, 21229, United States

Location

Related Publications (1)

• Wenzel K, Thomas J, Carrano J, Stidham J, Fishman M. A pilot randomized controlled trial of medication adherence therapy: Psychosocial leverage using a significant other (MAT-PLUS) for individuals on extended-release naltrexone. J Subst Use Addict Treat. 2024 Aug;163:209366. doi: 10.1016/j.josat.2024.209366. Epub 2024 Apr 16.

  PMID: 38636807 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Fishman, MD

  Maryland Treatment Centers/PHF

  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

Model Details: Open-label Treatment as Usual vs. Intervention

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 25, 2018
• Study Start: May 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)