Treating the Partners of Drug Using Pregnant Women: Stage II

Johns Hopkins University1 site in 1 country158 target enrollmentOctober 2005

ConditionsDrug Addiction

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Drug Addiction
Sponsor: Johns Hopkins University
Enrollment: 158
Locations: 1
Primary Endpoint: Partner Objective Substance Use
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

June 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Principal Investigator

Hendree E. Jones

Adjunct Professor

Johns Hopkins University

Eligibility Criteria

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