LFX-PGB Opioid Outpatient Withdrawal

Brief description of study

This study will examine the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal in an outpatient settings. The study timeline is Screening from 1-30 days; dosing for 1-7 days, and a sttudy medication taper on days 8, 9, 10; Day 8 is also 1st dose of Vivitrol; day 11 is f/U for wellness, and Day 28 is 2nd injection of Vivitrol The primary outcome will be measured by the Subjective Opioid Withdrawal Scale (SOWS) from the two arms collected in the study. The two arms are Lofexidine plus active pregabalin vs Lofexidine plus Placebo pregabalin. The secondary outcome measure is proportion that receive one or more doses of study medication and complete withdrawal (completion defined as receiving one or more doses of study medication on day 8); and proportion that transition to XR-NTX

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Medical Research
  • Age: - 99 Years
  • Gender: All

TBD

Updated on 09 Mar 2024. Study ID: 854046

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