Trial record 1 of 309 for:    (substance abuse OR addiction) AND (woman OR women OR female OR maternal OR pregnan)
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The Effect of Fetal Gender on Maternal Substance Abuse Treatment

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00882648
First received: April 15, 2009
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

Previous studies by this team of investigators has determined that male infants are more likely to display more severe neonatal abstinence syndrome (NAS) as a result of maternal opioid use during pregnancy (Jansson, 2007)and there is appears to be a gender-related biologic vulnerability to NAS expression (Jansson, 2009, submitted). The proposed study explores the relationship between fetal gender and substance abuse treatment outcomes among a population of women in comprehensive substance abuse treatment to explore the possibility of a psychosocial vulnerability among drug exposed male fetuses as opposed to female fetuses. Women in substance abuse treatment are a group at high risk for current exposure to violence, usually at the hands of significant others, and having a history of sexual abuse as a child, usually resulting from contact with a male family member. Therefore, they often have difficult relationships with men. At the Center for Addiction and Pregnancy (CAP), a 2006 study revealed that among a group of 715 pregnant women, reports of the exposure to violence was very high. Their rates of lifetime abuse ranged from 72.7% for physical abuse to 44.5% for sexual abuse. Rates of abuse remained high during their current pregnancy, ranging from 20% for physical abuse to 7.1% for sexual abuse (Velez, 2006). The abuse was very often at the hands of partners or other male family member perpetrators. We hypothesize that women carrying male fetuses will be less likely to remain complaint in drug treatment or abstinent from illicit drug use, while women carrying female fetuses may be more likely to remain drug abstinent and treatment compliant. If supported, this theory has the potential to inform fetal gender specific treatment for pregnant drug dependent women. Additionally, we seek to support the previously documented link between male gender and more severe expression of NAS, and explore the relationship between other maternal prescribed drug use (i.e. psychotropic medications) and severity of NAS expression.


Condition
Drug Dependence
Pregnancy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Effect of Fetal Gender on Maternal Substance Abuse Treatment

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Compliance with substance abuse treatment group and individual sessions and ability to maintain abstinence from illicit drug use [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Enrollment: 850
Study Start Date: April 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Drug dependent women
All drug dependent women enrolled in comprehensive substance abuse treatment at the Center for Addiction and Pregnancy of Johns Hopkins University between 2004 and 2009; retrospective chart review.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All women enrolled in comprehensive substance abuse treatment at the Center for Addiction and Pregnancy (CAP) between 2004 and 2009

Criteria

Inclusion Criteria:

  • All CAP clients who either experience a pregnancy loss, or deliver an infant while in treatment at CAP between the years 7/1/03 and 6/30/08

Exclusion Criteria:

  • All CAP clients who depart CAP treatment prior to pregnancy loss or birth during that time period
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00882648

Locations
United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided

Responsible Party: Lauren M. Jansson, Associate Professr of Pediatrics Johns Hopkins University School of Medicine, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00882648     History of Changes
Other Study ID Numbers: 19524, R01DA019934
Study First Received: April 15, 2009
Last Updated: February 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Drug dependence during pregnancy

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014