Clinical Research Directory

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.