Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 18 years - 65 year old
• Opioid-positive urine sample
• Current opioid use disorder with evidence of physical dependence
• Interest in undergoing opioid taper
Locations
United States
Maryland
University of Maryland
RECRUITING
Baltimore
Contact Information
Primary
Kelly E Dunn, Ph.D, M.B.A.
kelly.dunn@som.umaryland.edu
802-922-1682
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 60
Treatments
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).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Maryland, Baltimore