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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Yale University |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00227903 |
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 |
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Alcohol Abuse Cognitive Behavioral Therapy Brief Advice Cocaine Abuse Marijuana Abuse |
Behavioral: MI-CBT Behavioral: Brief Advice |
Phase II |
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) |
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 |
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MI-CBT: Experimental
Motivationally-enhanced cognitive behavioral skills counseling
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Behavioral: MI-CBT
Motivationally-enhanced cognitive behavioral skills counseling
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Brief Advice: Active Comparator
Advice and education
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Behavioral: Brief Advice
Advice and education
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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.
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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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Contact: Heather B Howell, MSW, LCSW | 2037646615 | heather.howell@yale.edu |
Contact: Sarah Saiano, MA | (203)764-8124 |
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 |
Principal Investigator: | Kimberly A Yonkers, M.D. | Yale University |
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 History of Changes |
Health Authority: | United States: Federal Government |
Cocaine-Related Disorders Mental Disorders Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Marijuana Abuse |
Cocaine-Related Disorders Mental Disorders Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Marijuana Abuse |