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OpenTrials
Completed

NCT Number: NCT00497302

Recovery Housing For Drug Dependent Pregnant Women

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).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RBT

Behavioral

Contingency management and behavioral counseling including motivational interviewing

Usual Care

Behavioral

receives usual comprehensive care at Center for Addiction and Pregnancy

Primary outcomes

  1. Treatment retention, drug free urine samples at follow-up and delivery

    Time frame: treatment entry until 12 months post treatment entry

Secondary outcomes

  1. prenatal care compliance, neonatal and birth outcomes

    Time frame: treatment entry until 12 months post treatment entry

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: HOME

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Jul 6, 2007
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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