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NCT04650386 · ClinicalTrials.gov registry record · NA
Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients
A NA study, sponsored by Public Health Management Corporation.
- Completed
- Registry status
- NA
- Development phase
- 125
- Enrollment target
NCT04650386: Completed NA study, sponsored by Public Health Management Corporation.
NCT04650386 is a NA study that has completed, run by Public Health Management Corporation. The registered enrollment target is 125 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04650386, a NA study, has completed, sponsored by Public Health Management Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 125 participants
- Enrollment target
Study Summary
The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in which the interventions are delivered based on the individual needs of patients at baseline and throughout the course of care. The adaptive intervention will incorporate certified recovery specialists (CRSs) and cognitive behavioral therapy (CBT), two interventions that have been widely used in the treatment of OUD. The efficacy of the adaptive intervention will be evaluated through a randomized controlled trial (RCT) that will be conducted in federally qualified health (FQHCs) in Philadelphia.
Primary Outcome
Participants will provide a urine specimen at the 3 month follow up assessment. We will use the CLIA Waived® 14-Panel Drug Test Cup and fentanyl test strip for opioids, buprenorphine, methadone, oxycodone, THC, cocaine, amphetamines, PCP, methamphetamine, benzodiazepines, and barbiturates, and MDMD. The urine sample will be delivered under the supervision of the RA who will use standard procedures to detect tampering and dilution.
Interventions
- BEHAVIORAL Psychosocial support determined by adaptive treatment algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2024-05-31 |
| Phase | NA |
What the finished NCT04650386 record still lists
NCT04650386 is an interventional study that assigns participants to a tested intervention. The registered 125 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 (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Psychosocial support determined by adaptive treatment algorithm is the first listed.
NCT04650386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04650386 about?
NCT04650386 is a clinical study titled "Examining an Adaptive Approach to Providing Psychosocial Support to Buprenorphine Patients". The purpose of this study is to address important knowledge gaps regarding the optimal way to provide psychosocial treatment to patients who are receiving buprenorphine for opioid use disorder (OUD) in office-based settings. The project will develop and evaluate an adaptive treatment approach in whi...
What is the current status of trial NCT04650386?
This trial is currently completed. It is a NA study. The enrollment target is 125 participants. The study started on 2020-09-21. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT04650386?
The interventions under investigation include: Psychosocial support determined by adaptive treatment algorithm (BEHAVIORAL).
Who is sponsoring clinical trial NCT04650386?
This trial is sponsored by Public Health Management Corporation, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04650386's enrollment target sits among peer trials
125 753rd of 2000 higher than 1,243 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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