NCT00497302

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:

  1. 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. 2.To determine whether financially supported abstinence-contingent recovery house placement plus individual counseling in pregnant drug-dependent women reduces prenatal drug use.
  3. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

3.6 years

First QC Date

July 5, 2007

Last Update Submit

March 1, 2013

Conditions

Drug Addiction

Keywords

cocaineopiatepregnancypost-partumneonatal abstinence syndromecontingency managementReinforcement Based Treatmentwomen

Outcome Measures

Primary Outcomes (1)

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

    treatment entry until 12 months post treatment entry

Secondary Outcomes (1)

  • prenatal care compliance, neonatal and birth outcomes

    treatment entry until 12 months post treatment entry

Study Arms (2)

1

EXPERIMENTAL

receives housing based on drug abstinence

Behavioral: RBT

2

ACTIVE COMPARATOR

Usual care treatment at the Center for Addiction and Pregnancy

Behavioral: usual care

Interventions

RBTBEHAVIORAL

Contingency management and behavioral counseling including motivational interviewing

1
usual careBEHAVIORAL

receives usual comprehensive care at Center for Addiction and Pregnancy

2

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersNeonatal Abstinence Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Hendree E Jones, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

November 1, 2004

Primary Completion

June 1, 2008

Study Completion

August 1, 2009

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)