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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00496990
First received: July 5, 2007
Last updated: March 1, 2013
Last verified: March 2013

July 5, 2007
March 1, 2013
October 2005
June 2009   (final data collection date for primary outcome measure)
Partner Objective Substance Use [ Time Frame: treatment entry until 28 weeks later ] [ Designated as safety issue: No ]
Partner Objective Substance Use [ Time Frame: treatment entry until 28 weeks later ]
Complete list of historical versions of study NCT00496990 on ClinicalTrials.gov Archive Site
Woman's drug use will be measured with urine toxicology [ Time Frame: treatment entry until 28 weeks later ] [ Designated as safety issue: No ]
Woman's drug usemeasured with urine toxicology [ Time Frame: treatment entry until 28 weeks later ]
Not Provided
Not Provided
 
Treating the Partners of Drug Using Pregnant Women: Stage II
Treating the Partners of Drug Using Pregnant Women: Stage II

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug Addiction
  • Behavioral: Enhanced care
    this group received counseling, contingency management and methadone or detoxification
  • Behavioral: control
    this group receives the opportunity to participate in a support group
  • Active Comparator: control
    Participants in this group receive the opportunity to attend a support group
    Intervention: Behavioral: control
  • 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
    Intervention: Behavioral: Enhanced care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
June 2010
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00496990
R01 DA013496, R01DA013496, DPMCDA
No
Hendree E. Jones, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Hendree Jones, PhD Johns Hopkins University
Johns Hopkins University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP