Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.
• Male and/or female subjects ≥ 18 years of age
• Meet DSM-5 criteria for an Opioid Use Disorder with physiologic features. Have met 2 or more of the 11 criteria for an OUD including tolerance and withdrawal within the last 12 months
• Interested in opioid antagonist treatment
• Used opioids in 20 or more of the last 30 days
• A stable address in the local area; not planning to move in the next 60 days.
• Have documents for ID check
• Absence of medical or psychiatric conditions that are likely to interfere with study participation
• Has 12 lead ECG demonstrating a QTc ≤450 msec and a QRS ≤120 msec. Site PI has final determination for study inclusion if readings exceed these limits. The PENN cardiologists and medical monitor are available for consultation when needed
• Negative pregnancy test and using adequate contraception if of childbearing potential.