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NCT06726200 · ClinicalTrials.gov registry record · Early Phase 1
A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use
A Early Phase 1 study of Opioid Use Disorder, sponsored by Rachel R. Luba.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06726200 is a Early Phase 1 study of Opioid Use Disorder that is actively recruiting participants, run by Rachel R. Luba. The registered enrollment target is 60 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06726200, a Early Phase 1 study of Opioid Use Disorder, is actively recruiting participants, sponsored by Rachel R. Luba.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for enrollment. The main questions it aims to answer are: Are there differences in frequency of drug use after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Are there differences in rates of sustained relapse after individuals start treatment with sublingual buprenorphine compared to injectable buprenorphine? Investigators also seek to understand and explore: How factors like body fat, body weight, and quantity of fentanyl use before treatment influence treatment outcomes. How blood levels of buprenorphine and its metabolite norbuprenorphine early on in treatment may influence treatment outcomes. How factors like craving and opioid withdrawal symptoms influence treatment outcomes. Participants will: Complete a brief overnight hospital stay in an inpatient research unit. This hospital stay will enable participants to start treatment with either sublingual buprenorphine or injectable buprenorphine. Provide blood and urine samples while on the inpatient unit and at follow up. Complete in-person follow up visits at 1-, 2-, 3- and 4-weeks after leaving the hospital to measure drug use, craving, withdrawal, quality of life, and physical health.
Conditions Studied
Interventions
- DRUG Buprenorphine + naloxone (Suboxone)
- DRUG Buprenorphine Injection
Study Locations (1)
New York
- Substance Treatment and Research Service - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-08 |
| Est. Completion | 2029-01-15 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06726200
The ClinicalTrials.gov registry entry for NCT06726200 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (99% lower). The listed sponsor is Rachel R. Luba, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Buprenorphine + naloxone (Suboxone) is the first listed.
NCT06726200 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06726200 about?
NCT06726200 is a clinical study titled "A Clinical Trial Comparing Buprenorphine Formulations for High Potency Synthetic Opioid Use". The goal of this clinical trial is to compare buprenorphine formulations (sublingual buprenorphine versus long-acting injectable buprenorphine) for treating opioid use disorder among individuals who use fentanyl and/or other high potency synthetic opioids. Individuals aged 18-65 will be eligible for...
What is the current status of trial NCT06726200?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2026-08. Estimated completion is 2029-01-15.
What conditions does trial NCT06726200 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT06726200?
The interventions under investigation include: Buprenorphine + naloxone (Suboxone) (DRUG), Buprenorphine Injection (DRUG).
Who is sponsoring clinical trial NCT06726200?
This trial is sponsored by Rachel R. Luba, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06726200 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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