Therapeutic Substance Abuse Treatment in Pregnancy - 1

Phase 2

Completed

Conditions: Alcohol Abuse
Cocaine Abuse
Marijuana Abuse

Interventions: Behavioral: Brief Advice
Behavioral: MI-CBT

Registration Number: NCT00227903

Lead Sponsor: Yale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 168

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Advice	Brief Advice	Advice and education
MI-CBT	MI-CBT	Motivationally-enhanced cognitive behavioral skills counseling

Primary Outcome Measures

Name	Time	Method
Percentage of Days Used Drugs or Alcohol	delivery to 3 months post-delivery
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol	Delivery to 3 months post-delivery
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol	Delivery to 3 months post-delivery

Secondary Outcome Measures

Name	Time	Method
Incidence of Preterm Births	At delivery
Incidence of Low Birth Weight	At delivery
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report	Delivery to 3 months post-delivery
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine	intake to delivery, an average of 21 weeks
Proportion of Participants Abstinent From Drugs According to Urine	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	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	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	Delivery to 3 months post-delivery
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine	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	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	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	Delivery to 3 months post-delivery	Based on urine tests for marijuana, cocaine or opioids