Evaluating opioid withdrawal symptoms during medication tapering
Official title: Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Run by University of Maryland, Baltimore · NCT05027919 · Data updated 2026-11-12
This study is testing how different people experience withdrawal symptoms when they slowly reduce their opioid use under medical supervision to help improve treatment for opioid use disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Status | Recruiting |
| Started | December 1, 2021 |
| Main results expected | November 30, 2026 |
| Study ends | February 28, 2027 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT05027919 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 65 with opioid use disorder who are interested in tapering off opioids.
✕Probably not a fit
Patients with significant dependence on alcohol or benzodiazepines requiring medical intervention or those currently in maintenance treatment with methadone or buprenorphine may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates individual differences in opioid withdrawal symptoms among individuals with opioid use disorder (OUD) while they undergo a medically supervised tapering process. Participants will stay in a residential research unit for 11 days, receiving morphine for the first five days, followed by a taper using lofexidine. The study includes two naloxone sessions to precipitate withdrawal symptoms, allowing researchers to collect data on withdrawal experiences and biological samples. The goal is to understand the variability in withdrawal symptoms to improve treatment strategies for OUD.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment approaches for individuals experiencing opioid withdrawal.
How similar studies have gone: Other studies have shown promise in understanding opioid withdrawal and improving treatment outcomes, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Maryland
Baltimore, Maryland, United States Recruiting
Study contacts
- Principal investigator: Kelly E Dunn, Ph.D, M.B.A. — University of Maryland
- Study coordinator: Kelly E Dunn, Ph.D, M.B.A.
- Email: kelly.dunn@som.umaryland.edu
- Phone: 802-922-1682
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using buspirone to help with opioid withdrawal
This study is testing if the medication buspirone can help people with opioid use disorder feel less withdrawal symptoms and cravings while they are tapering off opioids.
-
Canadian Emergency Department Opioid Registry (CEDRN)
This project will create a national emergency department registry to collect information on people of all ages who come to EDs with suspected or confirmed opioid poisoning to see if those data can guide better care and prevent deaths.
-
Measuring physiological symptoms during opioid withdrawal and cravings
This study is testing how the body reacts during opioid withdrawal and cravings in people with opioid dependence by using smartwatches to track their heart rate, skin temperature, and other signals over two weeks.
-
CBD for Opioid Dependence and Pain on Buprenorphine
This study tests whether different doses of cannabidiol (CBD) can affect pain and opioid cravings in adults with opioid use disorder who are on buprenorphine, using a short, randomized, placebo-controlled setup.
-
Cebranopadol for opioid withdrawal in adults with chronic pain
This study tests whether cebranopadol can reduce withdrawal symptoms in adults with chronic pain who are physically dependent on prescribed opioids, compared with placebo.
-
emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.