Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Exclusion Criteria19

• Current psychotic disorder (bipolar I, schizophrenia, major depression that is not in remission
• Alcohol, benzodiazepine, or other sedative use disorder with physiological features that require medication for detoxification
• Allergy or other serious adverse event due to treatment with pregabalin, XR-NTX, or lofexidine
• Pending incarceration or plans to leave the immediate area 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
• Blood pressure <90 mm Hg (systolic) or <60 mm Hg (diastolic). If value out of normal range, the investigator and study Clinician will decide subject inclusion/exclusion on case-by-case basis
• Heart rate and/or pulse<50 bpm at screening-sitting
• An Estimated Glomerular Filtration Rate eGFR<70 mL/min/1.73m2
• A History of, or current Seizure disorder (excluding childhood febrile seizures)
• Inability to read and/or understand English. For example, unable to understand the informed consent as demonstrated by failing to answer 9/10 questions correctly on the quiz
• 12\. Pregnant or breastfeeding
• 13\. Currently taking sympathomimetic drugs, or a thiazolidinedione antidiabetic
• ALT and/or AST >4X upper 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