Utility of Psychosocial Intervention in Improving Outcome for Methadone-exposed Infants and Their Mothers

NCT ID: NCT01889121

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-05-31

Brief Summary

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Opiate drug abuse/addiction is a significant co-morbidity in pregnancy. Opiate maintenance program enhances the outcome of pregnancies for the mother and the infant. Our objective was to assess if provision of structured psychosocial support in addition to methadone maintenance program adds incremental benefits with regards to the outcome of pregnancy.

Detailed Description

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Conditions

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Neonatal Abstinence Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Methadone maintenance program

Mothers on methadone treatment at time of delivery who delivered at Good Samaritan Hospital but were not enrolled in psychosocial intervention offered through the HOPE (Helping Opiate-addicted Pregnant women Evolve) program.

No interventions assigned to this group

Psychosocial intervention

Pregnant women who were in methadone maintenance program PLUS structured psychosocial intervention at the time of delivery (HOPE Program).

Structured psychosocial intervention

Intervention Type BEHAVIORAL

This is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention

Interventions

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Structured psychosocial intervention

This is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Positive Methadone tox screen
* Received care at Good Samaritan Hospital in Cincinnati
* Delivered at Good Samaritan Hospital

Exclusion Criteria

* Twin gestation
* Sever congenital anomalies
* Conditions requiring transfer to quaternary hospital
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Henry Akinbi

OTHER

Sponsor Role lead

Responsible Party

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Dr. Henry Akinbi

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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HOPE_Methadone

Identifier Type: -

Identifier Source: org_study_id