Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
University of Maryland, Baltimore
60 participants
Dec 1, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- years - 65 year old
- Opioid-positive urine sample
- Current opioid use disorder with evidence of physical dependence
- Interest in undergoing opioid taper
Exclusion Criteria7
- 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
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Interventions
Up to 120mg oral per day in q4 dosing to manage withdrawal
0.2-0.4mg naloxone injection during the Naloxone challenge + pretreatment with oral lofexidine (25% of max daily dose scheduled during lofexidine taper)
0.2-0.4mg naloxone injection during the Naloxone challenge
Oral Lofexidine dosed per FDA label (4 times daily) on days 6 through 10.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05027919