Treating the Partners of Drug Using Pregnant Women: Stage II

Phase 2

Completed

• Conditions: Drug Addiction
• Interventions: Behavioral: control; Behavioral: Enhanced care

• Registration Number: NCT00496990
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Primary Completion: 2009-06
• Study Completion: 2010-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	Participants in this group receive the opportunity to attend a support group
Enhanced care	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

Primary Outcome Measures

Name	Time	Method
Partner Objective Substance Use	treatment entry until 28 weeks later

Secondary Outcome Measures

Name	Time	Method
Woman's drug use will be measured with urine toxicology	treatment entry until 28 weeks later

Trial Locations

Locations (1)

Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States