Clinical trialNCT05995535RecruitingPhase 2Interventional

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

SponsorUniversity of PennsylvaniaEnrollment150Opiate Withdrawal SyndromeOpioid Use

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Mountain Manor Treatment Center
Baltimore, Maryland, United States
Marc Fishman, MD
Not, yet, recruiting
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States
Kyle M Kampman, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

LFX/PGBLFX/PLA-PGB

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jan 2024
Primary completion: 31 Aug 2026
Completion: 31 Aug 2026
Last update posted: 13 Feb 2026
Registered enrollment: 150
Registry id: NCT05995535

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.