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
  Purpose

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

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496990

Locations
United States, Maryland
Center for Addiction and Pregnancy Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Hendree Jones, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hendree E. Jones, Adjunct Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00496990     History of Changes
Other Study ID Numbers: R01 DA013496, 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:
male
female
couple
cocaine
opiate
methadone
detoxification
pregnancy

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 20, 2014