Trial · NCT03918850
Medication Treatment for Opioid Use Disorder in Expectant Mothers
NCT03918850, Phase 3, 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. Trials, record NCT03918850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03918850
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
- NCT number
- NCT03918850
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 140 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
- 2019-04-18
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Illicit Opioid-negative Urine Samples During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Illicit Opioid-negative Urine Samples Postpartum | Delivery through 12 months postpartum | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of illicit opioids and/or their metabolites. |
| Secondary | Percentage of Days With Study Medication Adherence During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Adherence to treatment from screening to delivery, checked weekly. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Days With Study Medication Adherence - Postpartum | Delivery through 12 months postpartum | Adherence to treatment from delivery through 12 months postpartum, checked weekly. |
| Secondary | Percentage of Drug and Alcohol-negative Urine Samples During Pregnancy | From screening (at 6-30 weeks estimated gestational age) to delivery, an average of 10-34 weeks | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. |
| Secondary | Percentage of Drug and Alcohol-negative Urine Samples - Postpartum Phase | Delivery through 12 months postpartum | Weekly urine samples are shipped to a central laboratory, where they are analyzed for presence of alcohol, illicit drugs and/or their metabolites, excluding cotinine. |
| Secondary | Opioid Craving Scale - Pregnancy | Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery | The scale consists of 3 items, measuring craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported. |
| Secondary | Opioid Craving Scale - Postpartum | Assessed at months 1, 3, 6, 9, and 12 post-delivery | The scale measures craving, cue-induced craving, and likelihood of using, rated on a visual analogue scale from 0-10. The total is calculated by averaging the 3 item scores. Higher scores indicate greater levels of opioid craving. The measure was assessed at months 1, 3, 6, 9, and 12 post-delivery, average score reported |
| Secondary | Adequacy of Prenatal Care Utilization Index | At delivery | The information was derived from either medical records or the birth certificate. Information was not obtained for 74 participants. |
| Secondary | Short Opiate Withdrawal Scale (SOWS)-Gossop - Pregnancy | Assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery | Measure of maternal opioid withdrawal symptoms. The Short Opiate Withdrawal Scale-Gossop has scores rated on a scale of 0 (none) to 3 (severe) per question. The total score of the SOWS-Gossop ranges from 0-30. Participants were randomized when they were 6-30 weeks estimated gestational age and, thus, the number of scheduled assessments varied between participants. The measure was assessed at randomization (6-30 weeks estimated gestational age), two weeks post randomization and then monthly until delivery, average score reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
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.
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT03918850
GET https://conductscience.org/api/trials/v1/NCT03918850/registered