Feasibility of the Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal
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|ClinicalTrials.gov Identifier: NCT03489161|
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : December 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Drug Overdose Opioid Withdrawal Opioid-use Disorder||Drug: Buprenorphine||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Utilization of Buprenorphine in the Emergency Room to Treat Clinical Opioid Withdrawal|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||August 28, 2018|
|Actual Study Completion Date :||August 28, 2018|
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.
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 [ Time Frame: Baseline ]Percentage of eligible potential participants who enroll in study
- Acceptability of transferral to outpatient clinic (MOTIVATE) [ Time Frame: 48 hours ]Percentage of eligible participants who complete additional screenings at MOTIVATE
- Feasibility of 5-Trial Delay Discounting [ Time Frame: Prior to drug administration (within 2 hours after participant is stabilized and consented) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489161
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Frederick G Moeller, MD||Virginia Commonwealth University|