Therapeutic Substance Abuse Treatment in Pregnancy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2010-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Alcohol Abuse Cocaine Abuse Marijuana Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MI-CBT

Motivationally-enhanced cognitive behavioral skills counseling

Group Type EXPERIMENTAL

MI-CBT

Intervention Type BEHAVIORAL

Motivationally-enhanced cognitive behavioral skills counseling

Brief Advice

Advice and education

Group Type ACTIVE_COMPARATOR

Brief Advice

Intervention Type BEHAVIORAL

Advice and education

Interventions

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MI-CBT

Motivationally-enhanced cognitive behavioral skills counseling

Intervention Type BEHAVIORAL

Brief Advice

Advice and education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No