Treating the Partners of Drug Using Pregnant Women: Stage II

Study Overview
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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.

Official Title
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Treating the Partners of Drug Using Pregnant Women: Stage II

Conditions
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Drug Addiction

Intervention / Treatment
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* Behavioral: Enhanced care
* Behavioral: control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>Participants in this group receive the opportunity to attend a support group | Behavioral: control<br>* this group receives the opportunity to participate in a support group<br>|
| Experimental: Enhanced care<br>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 | Behavioral: Enhanced care<br>* this group received counseling, contingency management and methadone or detoxification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partner Objective Substance Use |  | treatment entry until 28 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Woman's drug use will be measured with urine toxicology |  | treatment entry until 28 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy