Clinical Trial: Drug Treatment in Pregnancy - 1
This study is not yet open for patient recruitment.
Verified by National Institute on Drug Abuse (NIDA) September 2005
| 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 Behavior Therapy Brief Advice Cocaine Abuse Marijuana Abuse
| Behavior: Substance-Related Disorders
| Phase II
|
MedlinePlus related topics: Alcoholism; Cocaine; Marijuana
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):
Study start: September 2004
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 - 45 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
Pregnant women, age 16 or older, diagnosed with alcohol or drug abuse or dependence, report current or recent use -
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.
-
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00227903
Connecticut Bridgeport Hospital, Bridgeport, Connecticut, 06106, United States
Kimberly Yonkers 203-764-6621
Yale-New Haven Hospital, New Haven, Connecticut, 06510, United States
Kimberly A Yonkers, M.D. 203-764-6621 kimberly.yonkers@yale.edu
Study chairs or principal investigators
Kimberly A Yonkers, M.D., Principal Investigator, Yale University
More Information
Study ID Numbers: NIDA-19135-1; R01-19135-1
Last Updated: December 8, 2005
Record first received: September 27, 2005
ClinicalTrials.gov Identifier: NCT00227903
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Source: ClinicalTrials.gov
Cache Date: January 11, 2006