Trial · NCT03911466
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
NCT03911466, Completed, T. John Winhusen, PhD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study. Trials, record NCT03911466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03911466
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
- NCT number
- NCT03911466
- Status
- Completed
- Enrollment
- 97 participants, actual
- Lead sponsor
- T. John Winhusen, PhD
- Conditions
- Opioid-Related Disorders, Drug Addiction, Pregnancy Related, Substance Abuse, Drug Abuse, Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Drug Abuse in Pregnancy
- Interventions
- Buprenorphine Injection, Buprenorphine Sublingual Product
- First posted
- 2019-04-11
- Last updated
- 2026-03-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmin of buprenorphine and metabolites in plasma | 2 weeks post-randomization | A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model. |
| Primary | Cmin of buprenorphine and metabolites in plasma | 4 weeks post-randomization | A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model. |
| Primary | Fetal heart rate variability | Estimated gestational age (EGA) approximately 36 weeks | This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile). |
| Primary | Cmin of buprenorphine and metabolites in plasma | Estimated gestational age (EGA) approximately 36 weeks | A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model. |
| Primary | Cmax of buprenorphine and metabolites in plasma | Estimated gestational age (EGA) approximately 36 weeks | A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model. |
| Primary | Concentration of buprenorphine and metabolites in maternal plasma | Delivery | A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes. |
| Primary | Concentration of buprenorphine and metabolites in cord plasma | Delivery | Cord blood will be collected and used to estimate fetal exposure to buprenorphine. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37023858 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1DA013732 | The Ohio Valley Node of the Clinical Trials Network | WINHUSEN, T JOHN | UNIVERSITY OF CINCINNATI | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03911466
GET https://conductscience.org/api/trials/v1/NCT03911466/registered