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

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. Identifier: NCT00496990
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : March 5, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, 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.

Condition or disease Intervention/treatment Phase
Drug Addiction Behavioral: Enhanced care Behavioral: control Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
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
Study Start Date : October 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00496990

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)
Principal Investigator: Hendree Jones, PhD Johns Hopkins University

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

Keywords provided by Hendree E. Jones, Johns Hopkins University:

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