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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT00227903
First received: September 27, 2005
Last updated: June 14, 2013
Last verified: June 2013
  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:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Percentage of Days Used Drugs or Alcohol [ Time Frame: intake to delivery ] [ Designated as safety issue: Yes ]
  • Percentage of Days Used Drugs or Alcohol [ Time Frame: delivery to 3 months post-delivery ] [ Designated as safety issue: Yes ]
  • Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: Intake to delivery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol [ Time Frame: Intake to delivery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of Preterm Births [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
  • Incidence of Low Birth Weight [ Time Frame: At delivery ] [ Designated as safety issue: Yes ]
  • Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report [ Time Frame: Intake to delivery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of Participants Abstinent From Drugs According to Urine [ Time Frame: Intake to delivery ] [ Designated as safety issue: Yes ]
    Based on urine tests for marijuana, cocaine or opioids.

  • Proportion of Participants Abstinent From Drugs According to Urine [ Time Frame: Delivery to 3 months post-delivery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine [ Time Frame: Intake to delivery ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Based on urine tests for marijuana, cocaine or opioids


Other Outcome Measures:
  • Adequacy of Received Services [ Time Frame: After prenatal care initiation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The number of patients who attended outside treatment in the 30 days prior to each assessment.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Kimberly A Yonkers, M.D. Yale University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: June 14, 2013
Last Updated: June 14, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on November 27, 2014