Trials / Completed
CompletedNCT03911466
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 97 (actual)
- Sponsor
- T. John Winhusen, PhD · Academic / Other
- Sex
- Female
- Age
- 18 Years – 41 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Opioid-Related Disorders
- Drug Addiction
- Pregnancy Related
- Substance Abuse
- Drug Abuse
- Neonatal Abstinence Syndrome
- Neonatal Opioid Withdrawal Syndrome
- Drug Abuse in Pregnancy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Buprenorphine Injection | Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR). |
| DRUG | Buprenorphine Sublingual Product | Sublingual buprenorphine (BUP-SL), administered daily. |
Timeline
- Start date
- 2020-07-21
- Primary completion
- 2024-11-06
- Completion
- 2024-11-06
- First posted
- 2019-04-11
- Last updated
- 2026-03-16
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03911466. Inclusion in this directory is not an endorsement.