Recovery Housing For Drug Dependent Pregnant Women (HOME)

March 1, 2013 updated by: Hendree E. Jones, Johns Hopkins University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment retention, drug free urine samples at follow-up and delivery
Time Frame: treatment entry until 12 months post treatment entry
treatment entry until 12 months post treatment entry

Secondary Outcome Measures

Outcome Measure
Time Frame
prenatal care compliance, neonatal and birth outcomes
Time Frame: treatment entry until 12 months post treatment entry
treatment entry until 12 months post treatment entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Hendree E Jones, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 5, 2007

First Submitted That Met QC Criteria

July 5, 2007

First Posted (Estimate)

July 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 5, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA014979 (U.S. NIH Grant/Contract)
  • DPMCDA (Other Identifier: NIDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe