Treating the Partners of Drug Using Pregnant Women: Stage II

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

Clinical Phase

PHASE2/PHASE3

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-06-30

Brief Summary

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This is a two group randomized design that will compare a novel therapy package (i.e., Research supported treatment intervention, Contingency-based voucher incentives for the male partner's drug abstinence, Specialized MI couples counseling) to standard care for helping drug using partners of drug dependent pregnant women obtain and maintain drug abstinence. Participants will be followed for 22 weeks and have scheduled twice weekly urine sample collection and all participants will have follow-up interviews post-study entry.

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Detailed Description

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Conditions

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Drug Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

Participants in this group receive the opportunity to attend a support group

Group Type ACTIVE_COMPARATOR

control

Intervention Type BEHAVIORAL

this group receives the opportunity to participate in a support group

Enhanced care

Participants in this arm receive the opportunity to have detoxification or methadone treatment as well as receive vouchers contingent upon drug free urine samples and individualized counseling

Group Type EXPERIMENTAL

Enhanced care

Intervention Type BEHAVIORAL

this group received counseling, contingency management and methadone or detoxification

Interventions

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Enhanced care

this group received counseling, contingency management and methadone or detoxification

Intervention Type BEHAVIORAL

control

this group receives the opportunity to participate in a support group

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* are 18 years of age or older on admission;
* Pregnant as determined by sonogram results
* have a current sexual partner who they have seen recently at least 3 times a week
* male partner has regular alcohol or illicit drug use (at least 4 of 7 days typical use) and is not incarcerated.

Exclusion Criteria

* woman or partner report current suicidal ideation
* woman or partner meet diagnostic criteria for a current DSM-IV Axis I thought disorder (i.e. schizophrenia)
* woman or partner demonstrate significant cognitive impairment that precludes them from completing the initial assessment battery
* woman has evidence of physical violence or abuse

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No