Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal
University of Pennsylvania
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.
Description
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. It follows a UG3 study in which 90 inpatients with an OUD who expressed interest in XR-NTX were randomized 2:1 to withdrawal management with lofexidine/pregabalin or lofexidine/placebo pregabalin. Results were that the conditions were equally safe, and that lofexidine/pregabalin wa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugLFX/PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg
- DrugLFX/PLA-PGB
lofexidine tablets 0.18mg tabs pregabalin capsules 0mg
Locations (2)
- Mountain Manor Treatment CenterBaltimore, Maryland
- University of Pennsylvania, Treatment Research CenterPhiladelphia, Pennsylvania