Assessing a Clinically-meaningful Opioid Withdrawal Phenotype

• Status: Recruiting
• Trial end date: 2026-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Clonidine; Lofexidine; Morphine; Naloxone

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