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Treating the Partners of Drug Using Pregnant Women: Stage II

Treating the Partners of Drug Using Pregnant Women: Stage II

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00496990
Acronym
HOPE
Enrollment
158
Registered
2007-07-06
Start date
2005-10-31
Completion date
2010-06-30
Last updated
2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Addiction

Keywords

male, female, couple, cocaine, opiate, methadone, detoxification, pregnancy

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.

Interventions

BEHAVIORALcontrol

this group receives the opportunity to participate in a support group

BEHAVIORALEnhanced care

this group received counseling, contingency management and methadone or detoxification

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Partner Objective Substance Usetreatment entry until 28 weeks later

Secondary

MeasureTime frame
Woman's drug use will be measured with urine toxicologytreatment entry until 28 weeks later

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026