Recovery Housing For Drug Dependent Pregnant Women

Drug Addiction Clinical Trial

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Official title:

Recovery Housing For Drug Dependent Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497302
• Other study ID #: R01DA014979
• Secondary ID: R01DA014979DPMCD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: March 1, 2013
• Start date: November 2004
• Est. completion date: August 2009

Study information

• Verified date: March 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Addiction

Intervention

Behavioral:
• RBT
Contingency management and behavioral counseling including motivational interviewing
• usual care
receives usual comprehensive care at Center for Addiction and Pregnancy

Locations

Country	Name	City	State
United States	Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment retention, drug free urine samples at follow-up and delivery		treatment entry until 12 months post treatment entry	No
Secondary	prenatal care compliance, neonatal and birth outcomes		treatment entry until 12 months post treatment entry	No