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

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University Identifier:
First received: July 5, 2007
Last updated: March 1, 2013
Last verified: March 2013
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating the Partners of Drug Using Pregnant Women: Stage II

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Partner Objective Substance Use [ Time Frame: treatment entry until 28 weeks later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Woman's drug use will be measured with urine toxicology [ Time Frame: treatment entry until 28 weeks later ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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  DPMCDA 
Study First Received: July 5, 2007
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
pregnancy processed this record on May 04, 2016