An observational study in Opioid-Related Disorders, Drug Addiction and Pregnancy Related, sponsored by T. John Winhusen, PhD. Completed at 12 sites in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by T. John Winhusen, PhD · 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 58th largest by enrollment of the 122 observational ones that give a count, is one of 94 that started in 2020, is one of 122 observational ones, and was the 541st 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 to 41 Years · female · no healthy volunteers.
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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. 94 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 97 is below 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:
T. John Winhusen, PhD is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
T. John Winhusen, PhD has 6 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 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 128 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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This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial.
It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Injection
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Drug: Buprenorphine Sublingual Product
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Also known as: CAM2038
Sublingual buprenorphine (BUP-SL), administered daily.
Also known as: Subutex, Suboxone
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time frame: 2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time frame: 4 weeks post-randomization
Fetal heart rate variability
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Time frame: Delivery
Concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Time frame: Delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
Supporting information: Study protocol
Ran from Jul 2020 to primary completion in Nov 2024, 51 months.
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 51 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.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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T. John Winhusen, PhD