NCT05027919 Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
| NCT ID | NCT05027919 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Opioid Withdrawal |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2021-12-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Kelly E Dunn, Ph.D, M.B.A.
PRINCIPAL INVESTIGATOR
University of Maryland
Frequently Asked Questions
Who can join the NCT05027919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Opioid Withdrawal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05027919 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05027919 currently recruiting?
Yes, NCT05027919 is actively recruiting participants. Contact the research team at kelly.dunn@som.umaryland.edu for enrollment information.
Where is the NCT05027919 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05027919 clinical trial?
NCT05027919 is sponsored by University of Maryland, Baltimore. The principal investigator is Kelly E Dunn, Ph.D, M.B.A. at University of Maryland. The trial plans to enroll 60 participants.