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NCT03567356 · ClinicalTrials.gov registry record · NA
Treatment of Opioid Use: Medication Adherence Therapy
A NA study, sponsored by Potomac Health Foundations.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
NCT03567356 is a NA study that has completed, run by Potomac Health Foundations. The registered enrollment target is 45 participants.
The verdict
NCT03567356, a NA study, has completed, sponsored by Potomac Health Foundations.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
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.
Interventions
- OTHER MAT-PLUS "Helping Hands"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2023-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03567356
The ClinicalTrials.gov registry entry for NCT03567356 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Potomac Health Foundations, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MAT-PLUS "Helping Hands" is the first listed.
NCT03567356 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03567356 about?
NCT03567356 is a clinical study titled "Treatment of Opioid Use: Medication Adherence Therapy". 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 treatm...
What is the current status of trial NCT03567356?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2019-05-01. Estimated completion is 2023-06-01.
What interventions are being tested in trial NCT03567356?
The interventions under investigation include: MAT-PLUS "Helping Hands" (OTHER).
Who is sponsoring clinical trial NCT03567356?
This trial is sponsored by Potomac Health Foundations, which has 8 total clinical trials registered on ClinicalTrials.gov.
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