Skip to main content
OpenTrials
Completed

NCT Number: NCT00227903

Therapeutic Substance Abuse Treatment in Pregnancy - 1

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Cocaine Abuse Cocaine-Related Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Bridgeport Hospital, Bridgeport, Connecticut, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

MI-CBT

Behavioral

Motivationally-enhanced cognitive behavioral skills counseling

Brief Advice

Behavioral

Advice and education

Primary outcomes

  1. Percentage of Days Used Drugs or Alcohol

    Time frame: intake to delivery, an average of 21 weeks

  2. Percentage of Days Used Drugs or Alcohol

    Time frame: delivery to 3 months post-delivery

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Incidence of Preterm Births

    Time frame: At delivery

  2. Incidence of Low Birth Weight

    Time frame: At delivery

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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

  19. 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

  20. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PRIDE-P

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Sep 28, 2005
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.