Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05027919
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Craving
  • Opioid Use Disorder
  • Opioid Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydromorphone — DRUG
    Up to 120mg oral per day in q4 dosing to manage withdrawal
  • Naloxone + lofexidine pretreatment — DRUG
    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 — DRUG
    0.2-0.4mg naloxone injection during the Naloxone challenge
  • Lofexidine — DRUG
    Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.

Study Details

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

Key Dates

Start date
Dec 1, 2021
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

Withdrawal severity during lofexidine taper [ Time Frame: Days 6 through 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MarylandBaltimoreMaryland21201
Kelly E Dunn, PhD, MBA
[email protected]
802-922-1682
Kelly E Dunn, PhD, MBA (PRINCIPAL_INVESTIGATOR)

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By research site
University of Maryland· Baltimore, MD

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