Recovery Housing For Drug Dependent Pregnant Women (HOME)
Primary Purpose
Drug Addiction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RBT
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Drug Addiction focused on measuring cocaine, opiate, pregnancy, post-partum, neonatal abstinence syndrome, contingency management, Reinforcement Based Treatment, women
Eligibility 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
Sites / Locations
- Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
receives housing based on drug abstinence
Usual care treatment at the Center for Addiction and Pregnancy
Outcomes
Primary Outcome Measures
Treatment retention, drug free urine samples at follow-up and delivery
Secondary Outcome Measures
prenatal care compliance, neonatal and birth outcomes
Full Information
NCT ID
NCT00497302
First Posted
July 5, 2007
Last Updated
March 1, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00497302
Brief Title
Recovery Housing For Drug Dependent Pregnant Women
Acronym
HOME
Official Title
Recovery Housing For Drug Dependent Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women improves prenatal outpatient treatment retention.
To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
Keywords
cocaine, opiate, pregnancy, post-partum, neonatal abstinence syndrome, contingency management, Reinforcement Based Treatment, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
receives housing based on drug abstinence
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual care treatment at the Center for Addiction and Pregnancy
Intervention Type
Behavioral
Intervention Name(s)
RBT
Intervention Description
Contingency management and behavioral counseling including motivational interviewing
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
receives usual comprehensive care at Center for Addiction and Pregnancy
Primary Outcome Measure Information:
Title
Treatment retention, drug free urine samples at follow-up and delivery
Time Frame
treatment entry until 12 months post treatment entry
Secondary Outcome Measure Information:
Title
prenatal care compliance, neonatal and birth outcomes
Time Frame
treatment entry until 12 months post treatment entry
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendree E Jones, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Recovery Housing For Drug Dependent Pregnant Women
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