Home › Opioid Overdose › NCT05027919
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
RecruitingPhase 2
Who can join
Ages 18 to 65 · All sexes
Full eligibility criteria
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
About the study
Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.
What is being tested
- Hydromorphone (drug)
- Naloxone + lofexidine pretreatment (drug)
- Naloxone + placebo pretreatment (drug)
- Lofexidine (drug)
Sponsor: University of Maryland, Baltimore · Participants: 60 · Started: Dec 1, 2021
Contact the study team
- Kelly E Dunn, Ph.D, M.B.A. · Phone: 802-922-1682
Official record on ClinicalTrials.gov — NCT05027919
Locations in the U.S.
| Maryland | University of Maryland, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.