Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM) to Treat OPIOID Withdrawal

Inclusion Criteria

• Male and/or female subjects ≥ 18 years of age
• Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have 2 or more of the 11 DSM 5 criteria for opioid disorder including tolerance and withdrawal features in the last 12 months
• Interested in opioid antagonist treatment
• Have used opioids in 20 or more of the last 30 days
• Have a stable address in the local area; not planning to move; have documents for ID check
• Absence of medical or psychiatric conditions that are likely to interfere with study participation
• Have a 12 lead ECG demonstrating a QTc ≤450 msec and a QRS interval ≤120 msec. The site PI has the final determination for inclusion into the study for ECGs unless there is a question of QT prolongation or other factors (QTc/Fre uses the Frederica formula (QTc = QT/RR(1/3)). If consultation is needed, the PENN cardiologists and the medical monitor should be contacted
• If female, have a negative pregnancy test and uses adequate contraception if of childbearing potential

Exclusion Criteria

• Current psychotic disorder (bipolar I, schizophrenia, major depression with psychotic features,) as defined by the MINI
• An alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
• History of allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
• Pending incarceration in the next 30 days
• Homicidal or otherwise behaviorally disturbed requiring immediate attention.
• High Risk for suicide as determined by answering 'yes' to questions 4 and/or 5 on C-SSRS at screening
• Blood pressure 4X the top limit of normal
• A Child-Pugh score >7
• Currently receiving opioids for pain management
• In a treatment study where medication was administered in the last 30 days
• Currently using medications that are known to be strong or moderate inhibitors of CYP2D6 such as fluoxetine, paroxetine, mirabegron, bupropion, quinidine, terbinafine, cimetidine, cinacalcet, duloxetine, or fluvoxamine
• In a methadone maintenance or buprenorphine treatment program within the last 30 days