Evaluating opioid withdrawal symptoms during medication tapering
Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05027919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with opioid use disorder who are interested in tapering off opioids.
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.
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 performed: Other studies have shown promise in understanding opioid withdrawal and improving treatment outcomes, but this specific approach is novel.
Eligibility criteria
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 this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.