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Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

NCT05027919 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-12

No results posted yet for this study

Summary

Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.

Conditions

Interventions

DRUG

Hydromorphone

Up to 120mg oral per day in q4 dosing to manage withdrawal

DRUG

Naloxone + lofexidine pretreatment

0.2-0.4mg naloxone injection during the Naloxone challenge + pretreatment with oral lofexidine (25% of max daily dose scheduled during lofexidine taper)

DRUG

Naloxone + placebo pretreatment

0.2-0.4mg naloxone injection during the Naloxone challenge

DRUG

Lofexidine

Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Kelly E Dunn, Ph.D, M.B.A. · University of Maryland

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2026-11-30
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05027919 on ClinicalTrials.gov