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) plasma methadone levels.

Condition	Treatment or Intervention	Phase
Opioid-Related Disorders	Drug: Methadone	Phase II

Study #1 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. It stands to reason that methadone exposure may affect naturally occurring circadian and ultradian fetal rhythms and significantly affect fetal neurobehavioral organization in the newborn and developing child.

Ages Eligible for Study:  21 Years   -   40 Years,  Genders Eligible for Study:  Female

Criteria

Actively enrolled pregnant patients in CAP SA treatment.

Inclusion Criteria:

• Estimated gestational age of 30 weeks
• DSMIV criteria for opiod dependence according to e-module of the SCID
• Daily methadone maintenance at a stable dose for greater than a week

Exclusion Criteria:

• Concurrent DSMIV axis I diagnosis that would preclude informed consent procedures (i.e., schizophrenia, major depression) or confound study outcomes (e.g., Alcohol Dependence)
• Presence of a serious medical or psychiatric illness requiring chronic medication or other intervention (i.e., HIV infection) that may confound data interpretation
• Evidence of preterm labor
• Evidence of prescription drug use (e.g., antidepressants, tranquilizers)
• Presence of major congenital fetal malformation
• Recent use (last 5 days) of other illicit drugs (e.g., cocaine, marijuana) based on self report or positive on-Trak urine drug toxicology at time of actograph sessions
• Split methadone dosing schedule

Lauren M. Jansson, M.D.      (410)550-3415    ljansson@jhmi.edu

Maryland
      Center Addiction and Pregnancy, Baltimore,  Maryland,  21224,  United States; Recruiting

Study chairs or principal investigators

Lauren M. Jansson, M.D.,  Principal Investigator,  Johns Hopkins University   

Study ID Numbers:  NIDA-00495-1; K08-00495-1
Record last reviewed:  August 2003
Record first received:  August 12, 2003
ClinicalTrials.gov Identifier:  NCT00067184
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08