Sublingual Dexmedetomidine for Treating Opioid Withdrawal

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called BXCL501, which is a sublingual film (placed under the tongue) containing dexmedetomidine. This medication aims to help people experiencing withdrawal symptoms when they stop using opioids. Withdrawal symptoms can include feelings of anxiety, muscle pain, nausea, and trouble sleeping. The study will compare the safety and effectiveness of BXCL501 with another treatment called lofexidine and a placebo (a non-active treatment) in adults who are physically dependent on opioids.

To participate in this trial, you must be between 18 and 60 years old and have a moderate to severe opioid use disorder. You should not have certain health conditions, like significant heart problems or other serious medical issues. If you join the study, you will stay in the hospital for a week, where you will receive either BXCL501, lofexidine, or a placebo, while gradually reducing your opioid medication. This trial is important because it could provide a new, safer way to manage withdrawal symptoms without the risks associated with traditional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Capable of understanding and complying with the protocol.
• • 18 years of age or older but less than 60 years old.
• • Has opioid use disorder moderate-to-severe (304.00) as per DSM-V, and physiological dependence on opioids.
• • Females agree to use an acceptable method of contraception for the duration of the study.
• Exclusion Criteria:
• • Positive urine or serum pregnancy test at screening, after admission, planning to become pregnant during the course of the trial, or currently breast feeding.
• • Clinically significant history of cardiac disease, including syncope, bradycardia, conduction abnormalities, orthostatic hypotension or blood pressure disorders. Heart rate and blood pressure at screening and baseline of \< 50 beats per minute or systolic blood pressure \<105, \>150 mmHg or diastolic BP \<70, \>90 mmHg.
• • Clinically significant medical condition or observed abnormalities (including: physical examination, hypotension, laboratory evaluation, and/or urinalysis findings). Clinically significant abnormal ECG such as second- or third-degree heart block, uncontrolled arrhythmia, or QTc interval \> 450 msec for males, and \> 470 msec for females.
• • Evidence of hepatic abnormalities, including: ascites, bilirubin \>10% above upper limit of normal and/or esophageal variceal disease, active hepatitis/aspartate aminotransferase, alanine aminotransferase \>3x the upper limit of normal.
• • Any psychiatric disorder that would compromise ability to complete study requirements \[e.g. severe acute depression, active mania, or suicidality with specific plan and intent (assessed using the CSSRS)\].
• • Not being able to provide a negative urine for methadone or buprenorphine at screening.
• • Use of oral naltrexone for ≥7 consecutive days within 60 days prior to screening.
• • Need for alcohol or benzodiazepine detoxification.
• • Participation in a clinical trial of a pharmacological agent within 30 days prior to screening.
• • Use of any concomitant medication at screening or anticipated/required use during the study period that the investigators feel may impact participant safety or interfere with the aims of the trial (e.g., daily licit or illicit benzodiazepine use).
• • Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the protocol visit schedule or visit requirements.
• • Investigator-site personnel or immediate family of investigator-site personnel.