Therapeutic Substance Abuse Treatment in Pregnancy - 1 (PRIDE-P)

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Kimberly Yonkers, Yale University

ClinicalTrials.gov Identifier:

NCT00227903

First received: September 27, 2005

Last updated: August 7, 2012

Last verified: August 2012

History of Changes

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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Marijuana

U.S. FDA Resources

Further study details as provided by Yale University:

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 ]

Enrollment:	168
Study Start Date:	September 2004
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling	Behavioral: MI-CBT Motivationally-enhanced cognitive behavioral skills counseling
Active Comparator: Brief Advice 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 homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.

Contacts and Locations

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

Locations

United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06106
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Kimberly A Yonkers, M.D.

Yale University

More Information

Publications:

Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Jul 12. [Epub ahead of print]

Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. Epub 2009 Apr 7.

Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. Review.

Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-33.

Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. Epub 2012 May 11.

Responsible Party:	Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00227903 History of Changes
Other Study ID Numbers:	NIDA-19135-1, R01DA019135, R01-19135-1
Study First Received:	September 27, 2005
Last Updated:	August 7, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Cocaine-Related Disorders
Marijuana Abuse
Alcoholism

Substance-Related Disorders
Mental Disorders
Alcohol-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013

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