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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227903
Recruitment Status : Completed
First Posted : September 28, 2005
Results First Posted : August 21, 2013
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 28, 2005
Results First Submitted Date  ICMJE June 14, 2013
Results First Posted Date  ICMJE August 21, 2013
Last Update Posted Date April 15, 2020
Study Start Date  ICMJE September 2004
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • Percentage of Days Used Drugs or Alcohol [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Percentage of Days Used Drugs or Alcohol [ Time Frame: delivery to 3 months post-delivery ]
  • Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: Delivery to 3 months post-delivery ]
  • Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: Delivery to 3 months post-delivery ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • Incidence of Preterm Births [ Time Frame: At delivery ]
  • Incidence of Low Birth Weight [ Time Frame: At delivery ]
  • Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: Delivery to 3 months post-delivery ]
  • Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Proportion of Participants Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine, or opioids
  • Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine, or opioids.
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: Delivery to 3 months post-delivery ]
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: intake to delivery, an average of 21 weeks ]
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: Delivery to 3 months post-delivery ]
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids.
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: intake to delivery, an average of 21 weeks ]
    Based on urine tests for marijuana, cocaine or opioids
  • Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine [ Time Frame: Delivery to 3 months post-delivery ]
    Based on urine tests for marijuana, cocaine or opioids
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 14, 2013)
  • Adequacy of Received Services [ Time Frame: After prenatal care initiation ]
    Based on prenatal care attendance: the percent of visits attended after prenatal care initiation, accounting for time of delivery. Attendance was rated according to the Kotelchuck Adequacy of Prenatal Care Index. Only the normally scheduled prenatal car visits were included.
  • Attendance of Treatment Outside the Study [ Time Frame: 30 days prior to assessment ]
    The number of patients who attended outside treatment in the 30 days prior to each assessment.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Substance Abuse Treatment in Pregnancy - 1
Official Title  ICMJE Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Brief 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Abuse
  • Cocaine Abuse
  • Marijuana Abuse
Intervention  ICMJE
  • Behavioral: MI-CBT
    Motivationally-enhanced cognitive behavioral skills counseling
  • Behavioral: Brief Advice
    Advice and education
Study Arms  ICMJE
  • Experimental: MI-CBT
    Motivationally-enhanced cognitive behavioral skills counseling
    Intervention: Behavioral: MI-CBT
  • Active Comparator: Brief Advice
    Advice and education
    Intervention: Behavioral: Brief Advice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
168
Original Enrollment  ICMJE
 (submitted: September 27, 2005)
0
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227903
Other Study ID Numbers  ICMJE 0402026466
R01DA019135 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: only aggregate de-identified data
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Kimberly A Yonkers, M.D. Yale University
PRS Account Yale University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP