drugset
drugset / Trial / NCT05995535

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

NCT05995535 ↗

Phase 2 Recruiting 150 enrolled University of Pennsylvania
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-01-01
Primary completion
2026-08-31
Completion
2026-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregabalin Small molecule 600 mg —
Background Lofexidine Small molecule 2.16 mg —

Indications

substance withdrawal syndrome