NCT05027919

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Dec 2021

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Dec 2021Feb 2027

First Submitted

Initial submission to the registry

August 24, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

August 24, 2021

Last Update Submit

September 5, 2025

Conditions

Opioid WithdrawalOpioid Use DisorderOpioid Craving

Outcome Measures

Primary Outcomes (2)

  • Withdrawal severity during lofexidine taper

    Withdrawal severity as assessed by the Subjective Opioid Withdrawal Scale. (The score range is 0 through 64) with higher score indicating more severe withdrawal.

    Days 6 through 10

  • Withdrawal severity during naloxone challenge

    Withdrawal severity as assessed by the Subjective Opioid Withdrawal scale scores (The range is 0 through 64) with higher score indicating more severe withdrawal. Collected during two naloxone challenges (pretreatment with lofexidine and pretreatment with placebo).

    Days 1 through 5

Study Arms (1)

Within-subject design

OTHER

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).

Drug: HydromorphoneDrug: Naloxone + lofexidine pretreatmentDrug: Naloxone + placebo pretreatmentDrug: Lofexidine

Interventions

HydromorphoneDRUG

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

Within-subject design
Naloxone + lofexidine pretreatmentDRUG

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

Within-subject design
Naloxone + placebo pretreatmentDRUG

0.2-0.4mg naloxone injection during the Naloxone challenge

Within-subject design
LofexidineDRUG

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

Within-subject design

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

HydromorphoneNaloxonelofexidine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Kelly E Dunn, Ph.D, M.B.A.

    University of Maryland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The order of medication pre-treatment during the two Naloxone Challenges will be blinded to participants and the investigator.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 31, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)