NCT00496990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

3.7 years

First QC Date

July 5, 2007

Last Update Submit

March 1, 2013

Conditions

Drug Addiction

Keywords

malefemalecouplecocaineopiatemethadonedetoxificationpregnancy

Outcome Measures

Primary Outcomes (1)

  • Partner Objective Substance Use

    treatment entry until 28 weeks later

Secondary Outcomes (1)

  • Woman's drug use will be measured with urine toxicology

    treatment entry until 28 weeks later

Study Arms (2)

control

ACTIVE COMPARATOR

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

Behavioral: control

Enhanced care

EXPERIMENTAL

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

Interventions

Enhanced careBEHAVIORAL

this group received counseling, contingency management and methadone or detoxification

Enhanced care
controlBEHAVIORAL

this group receives the opportunity to participate in a support group

control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Lund IO, Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Female partners of opioid-injecting men in the Republic of Georgia: an initial characterization. Subst Abuse Treat Prev Policy. 2012 Nov 16;7:46. doi: 10.1186/1747-597X-7-46.

    PMID: 23157895DERIVED

  • Kirtadze I, Otiashvili D, O'Grady KE, Jones HE. Behavioral treatment + naltrexone reduces drug use and legal problems in the Republic of Georgia. Am J Drug Alcohol Abuse. 2012 Mar;38(2):171-5. doi: 10.3109/00952990.2011.643996. Epub 2012 Jan 5.

    PMID: 22221277DERIVED

  • Jones HE, Tuten M, O'Grady KE. Treating the partners of opioid-dependent pregnant patients: feasibility and efficacy. Am J Drug Alcohol Abuse. 2011 May;37(3):170-8. doi: 10.3109/00952990.2011.563336. Epub 2011 Mar 17.

    PMID: 21410418DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Hendree Jones, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

October 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2010

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

US(1)