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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00496990
First Posted: July 6, 2007
Last Update Posted: March 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Drug Addiction Behavioral: Enhanced care Behavioral: control Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating the Partners of Drug Using Pregnant Women: Stage II

Further study details as provided by Hendree E. Jones, Johns Hopkins University:

Primary Outcome Measures:
  • Partner Objective Substance Use [ Time Frame: treatment entry until 28 weeks later ]

Secondary Outcome Measures:
  • Woman's drug use will be measured with urine toxicology [ Time Frame: treatment entry until 28 weeks later ]

Enrollment: 158
Study Start Date: October 2005
Study Completion Date: June 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control
Participants in this group receive the opportunity to attend a support group
Behavioral: control
this group receives the opportunity to participate in a support group
Experimental: 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
Behavioral: Enhanced care
this group received counseling, contingency management and methadone or detoxification

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00496990


Locations
United States, Maryland
Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Hendree Jones, PhD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hendree E. Jones, Adjunct Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00496990     History of Changes
Other Study ID Numbers: R01DA013496 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Hendree E. Jones, Johns Hopkins University:
male
female
couple
cocaine
opiate
methadone
detoxification
pregnancy

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents