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Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Sponsor: University of Maryland, Baltimore
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.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-12-01
Completion Date
2027-02-28
Last Updated
2025-09-12
Healthy Volunteers
No
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.
Locations (1)
University of Maryland
Baltimore, Maryland, United States