An Early Phase 1 interventional study of Buprenorphine in Drug Overdose, Opioid Withdrawal and Opioid-use Disorder, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-13.
Sponsored by Virginia Commonwealth University · Early Phase 1, Interventional, and Treatment
Among 72 studies in Drug Overdose with a site in United States — 17 open to participants now, 28 under way, none of them phase 3. Drug Overdose · United States.
Among the 72 studies in Drug Overdose with a site in United States, this one is the 57th largest by enrollment of the 58 interventional ones that give a count, is one of 4 that started in 2018, is one of 2 in phase 1, and was the 19th registered.
104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.
Browse Drug Overdose studies →17 of the 72 studies in Drug Overdose with a site in United States are open now. Recruiting first, the newest first:
Boston Medical Center · Sites in United States
Ages 13+
San Francisco Department of Public Health · Sites in United States
Ages 18+ · Healthy volunteers
University of Wisconsin, Madison · Sites in United States
Ages 18+
Michele Staton · Sites in United States
Ages 18+ · Women only · Healthy volunteers
NYU Langone Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Drug Overdose studies recruiting now, 12 (92%) set no upper age limit and 1 (8%) stops at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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72 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 124 across 76 interventional studies indexed under Drug Overdose.
Median enrollment 182 across the 58 interventional studies, 217 across the 14 observational. Of the 40 that completed or were terminated, 18 (45%) have results posted.
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2 of 72 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 1 study filed under Drug Overdose — fewer than ten, so there is no comparison to draw.
8 of the studies in Drug Overdose with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07022717Boston Medical CenterA Universal Primary Care Based Intervention to Reduce Youth Overdose Risk | 2026-11 |
| NCT05320835Johns Hopkins Bloomberg School of Public HealthA Setting Focus Overdose Prevention Intervention | 2026-12-01 |
| NCT06236087NYU Langone HealthOverdose Prevention Centers and Behavioral Health | 2026-12-31 |
| NCT07170072NYU Langone HealthShelter HArm Reduction Evaluation | 2027-03-31 |
| NCT05657106April M YoungKentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk | 2027-05-31 |
Add all 8 to your calendar (.ics) → With an account.
Among the 72 studies in Drug Overdose with a site in United States, from their registry updates:
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The investigators are trying to determine whether they can effectively treat patients suffering from acute opioid withdrawal in the Emergency Department at Virginia Commonwealth University Health System (VCUHS) and subsequently transfer them to an outpatient addiction clinic within the existing infrastructure. This will be a descriptive investigation of the process to reveal areas of success and opportunities for improvement in order to determine feasibility of the study procedures in preparation for a larger clinical investigation.
Currently, patients in the Emergency Department at VCUHS experiencing opioid withdrawal, after reversal of opioid intoxication by naloxone, do not receive any direct treatment to stop the symptoms. They do receive indirect treatment aimed at each specific symptom, such as an anti-emetic to stop vomiting. The investigators propose directly treating all of the symptoms with the medication Suboxone, (buprenorphine/naloxone). Buprenorphine is a partial agonist on the Mu-receptor, which means it will provide less opioid effect than morphine, but should provide enough to make opioid withdrawal more tolerable. This is very important because stopping the withdrawal symptoms early will prevent the patient from quickly leaving and using opioids again, continuing their addiction cycle. The naloxone is included with buprenorphine as a deterrent to prevent intravenous injection of the drug for abuse. The investigators believe that if the patient is treated with Suboxone for withdrawal in the emergency department, and transported to the outpatient addiction treatment center at VCU, called the MOTIVATE clinic, the investigators can potentially break that cycle and help the patient work toward recovering. If successful, the investigators hope to improve the quality of life, prevent further overdose and death in those suffering from this deadly addiction.
Buprenorphine effectively treats the opioid withdrawal state. This has been demonstrated in many studies during the initial induction period with buprenorphine. Many of these patients are experiencing opioid withdrawal during this time. The sublingual dose can effectively be increased to resolve symptoms. According to many protocols and guidelines, acute opioid withdrawal is the preferred state of the patient when buprenorphine should be started.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Buprenorphine administered in the emergency room after patients presenting to the emergency department (ED) due to opioid OD who have been treated with opioid antagonist (naloxone) and are stable and alert.
Drug: Buprenorphine
buprenorphine/naloxone 4mg/1 mg for Clinical Opioid Withdrawal Scale (COWS) scores between 8 and 12, or 8mg/2mg S/L ≥ 12 by the sublingual route
Recruitment rates
Percentage of eligible potential participants who enroll in study
Time frame: Baseline
Acceptability of transferral to outpatient clinic (MOTIVATE)
Percentage of eligible participants who complete additional screenings at MOTIVATE
Time frame: 48 hours
Feasibility of 5-Trial Delay Discounting
Percentage of consented participants who complete this task, a brief (less than 1 minute) computer based task used to measure an individual's discounting rate when they are presented with the possibility of receiving a real reward
Time frame: Prior to drug administration (within 2 hours after participant is stabilized and consented)
Ran from Aug 2018 to primary completion in Aug 2018, 0 months.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Buprenorphine
Virginia Commonwealth University →