Recruiting
Phase 2

Observational Study

Sponsor:

University of Maryland, Baltimore

Code:

NCT05027919

Conditions

Opioid Withdrawal

Opioid Use Disorder

Opioid Craving

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hydromorphone

Naloxone + lofexidine pretreatment

Naloxone + placebo pretreatment

Lofexidine

Study Details

Brief 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

Opioid Withdrawal

Opioid Use Disorder

Opioid Craving

Study ID

NCT05027919

Start date

Dec 1, 2021

Status verified date

Sep, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years - 65 year old
  • Opioid-positive urine sample
  • Current opioid use disorder with evidence of physical dependence
  • Interest in undergoing opioid taper

Exclusion Criteria:

  • Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention
  • Being pregnant or breastfeeding
  • Enrolled in methadone or buprenorphine maintenance treatment
  • Clinically significant hypotension (<90/60mmHg) or bradycardia (<45bpm)
  • History of myocardial infarction
  • Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study)
  • Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Within-subject design

All participants will undergo the same study design, which includes hydromorphone stabilization (days 1-5), two naloxone challenges (scheduled during morphine stabilization), lofexidine-assisted taper (days 6-10), and transition to aftercare (day 11).

Interventions

Hydromorphone

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

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)

Naloxone + placebo pretreatment

0.2-0.4mg naloxone injection during the Naloxone challenge

Lofexidine

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

Primary outcome measure

  • Withdrawal severity during lofexidine taper [ Time Frame: Days 6 through 10 ]
  • Withdrawal severity during naloxone challenge [ Time Frame: Days 1 through 5 ]

Central Contacts and Locations

Central contacts

Kelly E Dunn, Ph.D, M.B.A.

802-922-1682kelly.dunn@som.umaryland.edu

Locations

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kelly E Dunn, PhD, MBA

802-922-1682kelly.dunn@som.umaryland.edu

Principal Investigator:

Kelly E Dunn, PhD, MBA

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-09-12.