Treating the Partners of Drug Using Pregnant Women: Stage II

Drug Addiction Clinical Trial

— HOPE  

Official title:

Treating the Partners of Drug Using Pregnant Women: Stage II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496990
• Other study ID #: R01DA013496
• Secondary ID: R01DA013496DPMCD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 5, 2007
• Last updated: March 1, 2013
• Start date: October 2005
• Est. completion date: June 2010

Study information

• Verified date: March 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Addiction

Intervention

Behavioral:
• Enhanced care
this group received counseling, contingency management and methadone or detoxification
• control
this group receives the opportunity to participate in a support group

Locations

Country	Name	City	State
United States	Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partner Objective Substance Use		treatment entry until 28 weeks later	No
Secondary	Woman's drug use will be measured with urine toxicology		treatment entry until 28 weeks later	No