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NCT03812107 · ClinicalTrials.gov registry record · NA
Response to Relapse in Office-Based Opioid Treatment Trial
A NA study, sponsored by Boston Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 115
- Enrollment target
NCT03812107: Clinical Trial NA study, sponsored by Boston Medical Center.
NCT03812107 is a NA study that was terminated before completion, run by Boston Medical Center. The registered enrollment target is 115 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03812107, a NA study, was terminated before completion, sponsored by Boston Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 115 participants
- Enrollment target
Study Summary
In a sample of individuals with co-occurring OUD and mental disorders, the investigators plan to test two medications for opioid use disorder (MOUD) treatment protocols that involve differing approaches to the use of opioids and other drugs during and after stabilization on MOUD - intensive vs. moderate treatment.The study is being conducted alongside the opening of a new clinical service funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) known as the Addiction and Behavioral Health Outpatient Recovery (ABOVE) program. The ABOVE Program is designed to treat patients with co-occurring opioid use disorder (OUD) and mental disorders with MOUD. Participants are individuals seeking treatment for co-occurring opioid use disorder (OUD) and mental disorders and are willing to receive MOUD treatment. Potential participants will be screened in the context of clinical care for opioid use disorder and mental disorders. If they are eligible for treatment in the ABOVE program, they will be asked to complete a baseline assessment, again for the purposes of clinical care. After completing the baseline clinical assessment, they will be asked to participate in this clinical trial, consented, then randomized. Treatment is delivered in the context of clinical care which involves delivery of MOUD and can involve psychiatric medications, and group and individual psychotherapy. Difference in treatment between the two randomization arms will only occur if a relapse to drug use occurs and will only involve two protocol-directed treatment responses to relapse.
Primary Outcome
This is a continuous measure of days a participant is prescribed medications for opioid use disorder for 24 weeks. For example, if the first prescription is for 7 days, then this measure has a minimum value of 7 days and a maximum value of approximately 168 days (24 weeks). If a participant is without MOUD prescribed by the ABOVE clinical program for 7 days or greater, then the participant will be considered discontinued from treatment for study purposes.
Interventions
- OTHER Moderate Treatment Approach
- OTHER Intensive Treatment Approach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2019-02-07 |
| Est. Completion | 2020-03-12 |
| Phase | NA |
Why NCT03812107 stopped before completion
NCT03812107 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Moderate Treatment Approach is the first listed.
NCT03812107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03812107 about?
NCT03812107 is a clinical study titled "Response to Relapse in Office-Based Opioid Treatment Trial". In a sample of individuals with co-occurring OUD and mental disorders, the investigators plan to test two medications for opioid use disorder (MOUD) treatment protocols that involve differing approaches to the use of opioids and other drugs during and after stabilization on MOUD - intensive vs. mode...
What is the current status of trial NCT03812107?
This trial is currently terminated. It is a NA study. The enrollment target is 115 participants. The study started on 2019-02-07. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT03812107?
The interventions under investigation include: Moderate Treatment Approach (OTHER), Intensive Treatment Approach (OTHER).
Who is sponsoring clinical trial NCT03812107?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03812107's enrollment target sits among peer trials
115 810th of 2000 higher than 1,190 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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