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Trial record 1 of 267 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:
ClinicalTrials.gov Identifier:
NCT00882648
First Posted: April 16, 2009
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lauren M. Jansson, National Institute on Drug Abuse (NIDA)
  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 Lauren M. Jansson, National Institute on Drug Abuse (NIDA):

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882648


Locations
United States, Maryland
The Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2009
First Posted: April 16, 2009
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Lauren M. Jansson, National Institute on Drug Abuse (NIDA):
Drug dependence during pregnancy

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