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Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

NCT05995535 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Opiate Withdrawal Syndrome
  • Opioid Use

Interventions

DRUG

LFX/PGB

lofexidine tablets 0.18mg tabs pregabalin capsules 100mg and 25mg

DRUG

LFX/PLA-PGB

lofexidine tablets 0.18mg tabs pregabalin capsules 0mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995535 on ClinicalTrials.gov