CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 168 enrolled
Drug / intervention
MI-CBT +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Pregnant women
  • ✓Age 16 or older
  • ✓Alcohol or illicit drug use in the past 30 days
Key exclusion· 7
  • ✕Not fluent in English or Spanish
  • ✕Pending incarceration
  • ✕Psychotic disorder
  • ✕Cognitively unable to give informed consent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00227903
NCT00227903Phase 2Completed
CompareCT.gov

Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)

Yale University·interventional·Posted Sep 28, 2005·Updated Apr 15, 2020

In Brief

A Phase 2 clinical trial evaluating MI-CBT and Brief Advice for Alcohol Abuse and 2 related conditions. Completed, enrolled 168 participants across 2 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Abuse, Cocaine Abuse, Marijuana Abuse
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2005
Enrollment StartSep 1, 2004
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.8 years ago

Interventions

MI-CBTbehavioral

Motivationally-enhanced cognitive behavioral skills counseling

Brief Advicebehavioral

Advice and education