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NCT03098407
Opioid Dependence Treatment Therapies in Pregnancy
NA trial testing Buprenorphine in Opioid-Related Disorders in 55 participants. Completed in 5 October 2020.
9 October 2019
Quick facts
| Lead sponsor | University of Pittsburgh |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 55 |
| Start date | 20 April 2017 |
| Primary completion | 9 October 2019 |
| Estimated completion | 5 October 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Buprenorphine (BUPRENORPHINE) — full drug profile →
- Methadone (METHADONE) — full drug profile →
Conditions studied
- Opioid-Related Disorders — all drugs for Opioid-Related Disorders →
- Pregnancy — all drugs for Pregnancy →
Sponsor
University of Pittsburgh
Who can join
18 and older, female only, with Opioid-Related Disorders or Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The incidence of opioid dependence in pregnancy increased over the last decade from 1.2 to 5.8 per 1,000 hospital births per year.1 While methadone is the current, standard treatment for opioid dependent (OD) pregnant women, buprenorphine recently emerged as an alternative. In a recent clinical trial (MOTHER), buprenorphine was associated with superior neonatal outcomes such as shorter duration of treatment for neonatal abstinence syndrome (NAS) compared to methadone. However, buprenorphine was also associated with greater study discontinuation (33% vs. 18%) and illicit opioid use (33% vs. 23%) compared to methadone. Treatment dropout often leads to relapse and resumption of high-risk behaviors, overshadowing any short-term improvement in neonatal outcomes. Therefore, The goal of this K23 proposal is to conduct a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone programs for the treatment of OD pregnant women. A pilot study is critical to develop the outcome measures, assessment tools and participant tracking techniques necessary for a future, large-scale comparative effectiveness clinical trial. An examination of feasibility and acceptability will also allow use to characterize the subpopulations of OD pregnant women willing to participate in treatment randomization, identify patient and provider characteristics associated with established treatment preferences and inform the development of strategies to improve participation and enhance the generalizability of the future large-scale clinical trial.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03098407
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06406400 — Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics o · Phase 1 · terminated
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Other recruiting trials for Opioid-Related Disorders
Currently open trials in the same condition.
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Other University of Pittsburgh trials
Trials by the same sponsor.
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- NCT06488469 — Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03098407 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pittsburgh
- Last refreshed: 9 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03098407.
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