NCT00078143

Brief Summary

The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2003

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

February 19, 2004

Last Update Submit

January 11, 2017

Conditions

Substance-Related Disorders

Keywords

behavioral intervention

Outcome Measures

Primary Outcomes (2)

  • Treatment Utilization

  • Substance Abuse

Interventions

Behavior TherapyBEHAVIORAL

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy \<30 weeks
  • Have not attended drug treatment in past 28 days
  • Not needing residential treatment (except detox)
  • Not at risk for suicide/homicide
  • Have no pending legal charges (except drug treatment)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Midtown Community Mental Health Center

Indianapolis, Indiana, 46202, United States

Location

Jefferson Alcohol & Drug Abuse Center

Louisville, Kentucky, 40202, United States

Location

Eleonore Hutzel Recovery Center

Detroit, Michigan, 48201, United States

Location

Milagro Clinic

Albuquerque, New Mexico, 87106, United States

Location

Milagro

Albuquerque, New Mexico, 87106, United States

Location

Coastal Horizons Center, Inc.

Wilmington, North Carolina, 28412, United States

Location

Related Publications (2)

  • Osterman R, Lewis D, Winhusen T. Efficacy of motivational enhancement therapy to decrease alcohol and illicit-drug use in pregnant substance users reporting baseline alcohol use. J Subst Abuse Treat. 2017 Jun;77:150-155. doi: 10.1016/j.jsat.2017.02.003. Epub 2017 Feb 21.

    PMID: 28254158DERIVED

  • Winhusen T, Lewis D. Cigarette smoking in pregnant substance users: Association with substance use and desire to quit. J Addict Dis. 2017 Jan-Mar;36(1):88-91. doi: 10.1080/10550887.2016.1254992. Epub 2016 Nov 1.

    PMID: 27802114DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Theresa Winhusen, Ph.D.

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2004

First Posted

February 23, 2004

Study Start

October 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(6)