An observational study in Opioid-use Disorder, Opioid Use, Unspecified and Buprenorphine Dependence, sponsored by Senthil Sadhasivam. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Senthil Sadhasivam · Observational
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Among 1,222 studies in Opioid-Related Disorders with a site in United States — 245 open to participants now, 315 under way, 18 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 19th largest by planned enrollment of the 122 observational ones that give a count, is one of 51 that started in 2018, is one of 122 observational ones, reaches primary completion later than 77 of the 314 other live ones, and was the 500th registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →245 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Massachusetts, Worcester · Sites in United States
Ages 18+ · Healthy volunteers
Baylor College of Medicine · Sites in United States
Ages 18–64
Yale University · Sites in United States
Ages 25–65 · Healthy volunteers
Adneuris Therapeutics, Inc. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
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1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 99 · Phase 4 79
First in 1988; this study’s year is marked. 51 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 129 across 184 observational studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 834 that completed or were terminated, 331 (40%) have results posted.
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132 of 1,222 have an industry lead sponsor. The 10 most frequent:
Senthil Sadhasivam is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Senthil Sadhasivam has 3 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
129 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Add all 129 to your calendar (.ics) → With an account.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
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The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).
One of the greatest impacts on maternal/infant health in the United States today is mother's who have opioid use disorder also known as OUD. This study will look at how in-utero buprenorphine also known as subutex, effects both mother/fetus in prenatal stages with MRI's, blood draws, and a series of assessments. After the neonate is born, there will be follow-up with that baby for up to 2 years with another neonatal MRI, blood draws and infant/child assessments. Planning to enroll 200 mothers who have opioid use disorder and 100 mothers with no previous opioid use.
Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
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Exclusion Criteria:
Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine
Drug: Subutex / Buprenorphine · Diagnostic Test: Fetal & Neonatal MRI · Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder.
Diagnostic Test: Fetal & Neonatal MRI · Diagnostic Test: DNA/Genetic/Pharmacokenetic Blood Draws
Drug page: Buprenorphine
Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.
Incidence of opioid misuse severity using assessments
Incidence of opioid misuse severity and buprenorphine treatment response will be assessed by the treating physician using assessments such as Who Assist, TCU Motform, Adverse Childhood Experience Assessment, Ham-A and Ham-D.
Time frame: 5 years
Pharmacological treatment for neonatal abstinence syndrome
Incidence of Neonatal Abstinence Syndrome and need for pharmacological treatment.
Time frame: 5 years
Incidence of adverse effects of buprenorphine using MRI
Incidence of adverse effects of buprenorphine use on fetal and placental changes using MRI.
Time frame: 5 years
Concentration of long-term neurodevelopmental outcomes using assessments
Concentration of long-term neurodevelopmental outcomes in neonates using the Ages and Stages Questionnaire and the Baileys follow-up assessment.
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2018 (actual). Primary completion is estimated for Dec 2026, 99 months after the start.
Of 74 non-industry observational studies under Opioid-Related Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 99 months is above that.
Counting every sponsor, half of 88 studies reached it within 27 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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Senthil Sadhasivam