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Recovery Housing For Drug Dependent Pregnant Women (HOME)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00497302
First received: July 5, 2007
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  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: RBT
Behavioral: usual care
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recovery Housing For Drug Dependent Pregnant Women

Resource links provided by NLM:

MedlinePlus related topics: Prenatal Care
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Treatment retention, drug free urine samples at follow-up and delivery [ Time Frame: treatment entry until 12 months post treatment entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • prenatal care compliance, neonatal and birth outcomes [ Time Frame: treatment entry until 12 months post treatment entry ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: November 2004
Study Completion Date: August 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
receives housing based on drug abstinence
 Behavioral: RBT
Contingency management and behavioral counseling including motivational interviewing
Active Comparator: 2
Usual care treatment at the Center for Addiction and Pregnancy
 Behavioral: usual care
receives usual comprehensive care at Center for Addiction and Pregnancy

  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
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Hendree E. Jones, Adjunct Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00497302     History of Changes
Other Study ID Numbers: R01 DA014979, R01DA014979, DPMCDA
Study First Received: July 5, 2007
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
cocaine
opiate
pregnancy
post-partum
 neonatal abstinence syndrome
contingency management
Reinforcement Based Treatment
women

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Mental Disorders
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on June 17, 2013