Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
NCT ID: NCT05027919
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2021-12-01
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Opioid-positive urine sample
* Current opioid use disorder with evidence of physical dependence
* Interest in undergoing opioid taper
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Maryland, Baltimore
OTHER
Responsible Party
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Principal Investigators
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Kelly E Dunn, Ph.D, M.B.A.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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University of Maryland
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00279895
Identifier Type: -
Identifier Source: org_study_id
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