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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Johns Hopkins University |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00067184 |
Purpose
The purpose of this study is to examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) maternal plasma methadone levels.
| Condition | Intervention |
|
Opioid-Related Disorders |
Device: Toitu 320/325 |
| Drug Information available for: | Methadone Methadone hydrochloride Buprenorphine Buprenorphine hydrochloride |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Methadone, Buprenorphine and Fetal Development |
| Estimated Enrollment: | 180 |
| Study Start Date: | September 2002 |
| Estimated Study Completion Date: | August 2010 |
This study will examine differences in fetal neurobehavior at peak (2 hours after oral dose) vs. trough (2 hours before oral dose) plasma methadone levels. Anecdotal clinical observations suggest that fetal activity is increased at trough methadone levels and decreased at peak methadone levels, yet we do not understand how in utero methadone exposure affects fetal neurobehavioral state development.
Eligibility
| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Methadone exposed pregnancies
Actively enrolled pregnant patients in CAP SA treatment.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lauren M. Jansson, M.D. | (410)550-5438 | ljansson@jhmi.edu |
| United States, Maryland | |||||
| Center for Addiction and Pregnancy | Recruiting | ||||
| Baltimore, Maryland, United States, 21224 | |||||
| Contact: Lauren M. Jansson, M.D. 410-550-5438 ljansson@jhmi.edu | |||||
| National Institute on Drug Abuse (NIDA) |
| Johns Hopkins University |
| Principal Investigator: | Lauren M. Jansson, M.D. | Johns Hopkins University |
More Information
| Responsible Party: | Johns Hopkins University School of Medicine ( Lauren Jansson / Assistant Professor of Pediatrics ) |
| Study ID Numbers: | HBV98112004, NIDA R01DA019934 |
| First Received: | August 12, 2003 |
| Last Updated: | October 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00067184 |
| Health Authority: | United States: Federal Government |
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