Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal (RELEASE)

This is an interventional treatment trial for Opioid Withdrawal Read More

Inclusion Criteria:

A patient will be eligible for inclusion in the study if he or she meets the following criteria:

1. Male and female patients between the ages of 18-64, inclusive.
2. Patients who have met DSM-5 criteria for moderate to severe opioid use disorder confirmed by the Mini-International Neuropsychiatric Interview (MINI) with physiological dependence as evidenced by a Clinical Opiate Withdrawal (COWS) score of >5 or a positive naloxone challenge upon inpatient admission.
3. Patients who read, understand, and provide written informed consent.
4. Participants who agree to use a medically acceptable and effective birth control method.

Exclusion Criteria:

A patient will be excluded from the study if he or she meets the following criteria:

1. Female patients who have a positive urine pregnancy test at screening or when tested or currently breast feeding.
2. Clinically significant history of cardiac disease.
3. History or presence of a significant medical disease or disorder.
4. Hepatic dysfunction at the screening visit.
5. Acute active Hepatitis B or C.
6. Patients with ECG abnormalities considered clinically significant by the investigator.
7. Any psychiatric disorder that would compromise ability to complete study requirements.
8. Currently meets DSM-5 criteria for substance abuse disorder, moderate or severe, for any substance other than opioids, caffeine, or nicotine.
9. History of suicidal behavior within the last 1 year prior to screening.
10. Patients who have received an investigational drug within 30 days prior to screening.
11. Use of any excluded medication at screening or anticipated/required use during the study period.
12. Patients with a history of intolerance to morphine.
13. Any finding that, in the view of the investigator, would compromise the patient's ability to fulfill the protocol visit schedule or visit requirements.