Clinical trial NCT00497302: Recovery Housing For Drug Dependent Pregnant Women
Official title: Recovery Housing For Drug Dependent Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Drug Addiction
Keywords: cocaine
opiate
pregnancy
post-partum
neonatal abstinence syndrome
contingency management
Reinforcement Based Treatment
women
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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).


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

Primary outcomes:
measure: Treatment retention, drug free urine samples at follow-up and delivery
timeFrame: treatment entry until 12 months post treatment entry
Secondary outcomes:
measure: prenatal care compliance, neonatal and birth outcomes
timeFrame: treatment entry until 12 months post treatment entry
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Center for Addiction and Pregnancy Jhons Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hendree E Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: