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Treating the Partners of Drug Using Pregnant Women: Stage II (HOPE)

Primary Purpose

Drug Addiction

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced care
control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drug Addiction focused on measuring male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control

Enhanced care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Partner Objective Substance Use

Secondary Outcome Measures

Woman's drug use will be measured with urine toxicology

Full Information

First Posted
July 5, 2007
Last Updated
March 1, 2013
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00496990
Brief Title
Treating the Partners of Drug Using Pregnant Women: Stage II
Acronym
HOPE
Official Title
Treating the Partners of Drug Using Pregnant Women: Stage II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction
Keywords
male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Active Comparator
Arm Description
Participants in this group receive the opportunity to attend a support group
Arm Title
Enhanced care
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Enhanced care
Intervention Description
this group received counseling, contingency management and methadone or detoxification
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
this group receives the opportunity to participate in a support group
Primary Outcome Measure Information:
Title
Partner Objective Substance Use
Time Frame
treatment entry until 28 weeks later
Secondary Outcome Measure Information:
Title
Woman's drug use will be measured with urine toxicology
Time Frame
treatment entry until 28 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendree Jones, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23157895
Citation
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.
Results Reference
derived
PubMed Identifier
22221277
Citation
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.
Results Reference
derived
PubMed Identifier
21410418
Citation
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.
Results Reference
derived

Learn more about this trial

Treating the Partners of Drug Using Pregnant Women: Stage II

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