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Recovery Housing For Drug Dependent Pregnant Women (HOME)
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00497302
  Purpose

For the past several years our research program has developed and tested an intensive outpatient intervention that is based in social learning theory and employs abstinence contingent access to recovery housing as a routine aspect of an intensive day treatment counseling program. The present project proposes to extend this treatment intervention to the special population of pregnant drug using women enrolled at the Center for Addiction and Pregnancy (CAP). We will compare an enhanced treatment that includes abstinence contingent recovery house living plus intensive individual therapy, to standard care at the CAP program. Specific aims of the project are derived from testing a two-group design are described below:

  1. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.
  2. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
  3. To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling results in better maternal and infant clinical birth outcomes (e.g., birth weight, estimated gestational age (EGA) at delivery, medical complications).

Condition Intervention Phase
Drug Addiction
Behavioral: contingency management
Behavioral: Reinforcement Based Treatment
Phase II
Phase III

MedlinePlus related topics: Prenatal Care
Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Recovery Housing For Drug Dependent Pregnant Women

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Treatment retention, drug free urine samples at follow-up and delivery [ Time Frame: treatment entry until 12 months post treatment entry ]

Secondary Outcome Measures:
  • prenatal care compliance, neonatal and birth outcomes [ Time Frame: treatment entry until 12 months post treatment entry ]

Estimated Enrollment: 128
Study Start Date: November 2004
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CAP enrolled
  • Age 18 or older
  • Evidence of use of opiate and/or cocaine use in the past 30 days
  • Assigned to pharmacotherapy free modality
  • CAP admission at an estimated gestational age (EGA) <34 weeks

Exclusion criteria:

  • Endorses current suicidal ideation
  • Any medical disorders requiring extended or future hospitalization
  • Meet diagnostic criteria for current DSM-IV alcohol dependence
  • Meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
  • Demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497302

Locations
United States, Maryland
Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
  More Information

Study ID Numbers: RO1 DA 14979
Study First Received: July 5, 2007
Last Updated: May 27, 2008
ClinicalTrials.gov Identifier: NCT00497302  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
cocaine
opiate
pregnancy
post-partum
neonatal abstinence syndrome
contingency management
Reinforcement Based Treatment
women
pregnancy

Study placed in the following topic categories:
Behavior, Addictive
Mental Disorders
Neonatal Abstinence Syndrome
Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

ClinicalTrials.gov processed this record on January 16, 2009