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Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal — UH3  

Opioid Use Clinical Trial

Official title:
Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Clinical Trial 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.

Clinical Trial 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 was more effective in reducing subjective withdrawal and keeping patients in treatment than lofexidine/placebo pregabalin. The objectives are to study the safety and effectiveness of lofexidine/pregabalin compared to lofexidine/placebo for managing opioid withdrawal and transitioning to XR-NTX in outpatient settings. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05995535
Study type Interventional
Source University of Pennsylvania
Contact Kyle M Kampman, MD
Phone 215-746-2764
Email Kampman@pennmedicine.upenn.edu
Status Recruiting
Phase Phase 2
Start date January 1, 2024
Completion date August 31, 2026
View Details
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