Therapeutic Substance Abuse Treatment in Pregnancy - 1 - Full Text View

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Yale University
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00227903

Purpose

The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).

Condition	Intervention	Phase
Alcohol Abuse Cognitive Behavioral Therapy Brief Advice Cocaine Abuse Marijuana Abuse	Behavioral: MI-CBT Behavioral: Brief Advice	Phase II

MedlinePlus related topics: Marijuana

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Drug free days [ Time Frame: during pregnancy and during 1st 3 months postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

STD testing (incl HIV) [ Time Frame: during pregnancy and during 1st 3 months postpartum ] [ Designated as safety issue: Yes ]
Birth outcomes (gestational age, birthweight) [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MI-CBT: Experimental Motivationally-enhanced cognitive behavioral skills counseling	Behavioral: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling
Brief Advice: Active Comparator Advice and education	Behavioral: Brief Advice Advice and education

Detailed Description:

We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.

Eligibility

Ages Eligible for Study:	16 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

Exclusion Criteria:

Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homocidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227903

Contacts

Contact: Heather B Howell, MSW, LCSW	2037646615	heather.howell@yale.edu
Contact: Sarah Saiano, MA	(203)764-8124

Locations

United States, Connecticut
Bridgeport Hospital	Recruiting
Bridgeport, Connecticut, United States, 06106
Contact: Heather B Howell, MSW 203-764-6615 heather.howell@yale.edu
Contact: Kimberly Beauchemin, RN (203)764-6764
Principal Investigator: Kimberly A Yonkers, MD
Sub-Investigator: Edward Luchansky, MD
Yale-New Haven Hospital	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Heather B Howell, MSW 203-764-6615 heather.howell@yale.edu
Contact: Sarah Saiano, MA (203)764-8124
Principal Investigator: Kimberly A Yonkers, MD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Yale University

Investigators

Principal Investigator:

Kimberly A Yonkers, M.D.

Yale University

More Information

Study website This link exits the ClinicalTrials.gov site

Responsible Party:	Yale University School of Medicine, Dept of Psychiatry ( Kimberly Ann Yonkers, MD )
Study ID Numbers:	NIDA-19135-1, R01-19135-1
Study First Received:	September 27, 2005
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00227903
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Mental Disorders
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Marijuana Abuse

ClinicalTrials.gov processed this record on January 16, 2009