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

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Drug Addiction

Treatments: Behavioral: Enhanced care; Behavioral: control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00496990

R01DA013496 (U.S. NIH Grant/Contract)

DPMCDA

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 2 patient groups

control

Active Comparator group

Description:

Participants in this group receive the opportunity to attend a support group

Treatment:

Behavioral: control

Enhanced care

Experimental group

Description:

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

Treatment:

Behavioral: Enhanced care