Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male and/or female subjects ≥ 18 years of age 2. 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 3. Interested in opioid antagonist treatment 4. Used opioids in 20 or more of the last 30 days 5. A stable address in the local area; not planning to move in the next 60 days. 6. Have documents for ID check 7. Absence of medical or psychiatric conditions that are likely to interfere with study participation 8. 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 9. Negative pregnancy test and using adequate contraception if of childbearing potential. Exclusion Criteria: 1. Current psychotic disorder (bipolar I, schizophrenia, major depression that is no