RecruitingPhase 2NCT05995535

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

Sponsor

University of Pennsylvania

Enrollment

150 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Opioid Use Opiate Withdrawal Syndrome

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LFX/PGB and a drug called LFX/PLA-PGB for people with opiate withdrawal syndrome and opioid use. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Center

Baltimore, Maryland, United States

University of Pennsylvania, Treatment Research Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05995535

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