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

Yale University logo

Yale University

Status and phase

Completed
Phase 2

Conditions

Marijuana Abuse
Cocaine Abuse
Alcohol Abuse

Treatments

Behavioral: MI-CBT
Behavioral: Brief Advice

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00227903
R01DA019135 (U.S. NIH Grant/Contract)
0402026466

Details and patient eligibility

About

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).

Full 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.

Enrollment

168 patients

Sex

Female

Ages

16 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

168 participants in 2 patient groups

MI-CBT
Experimental group
Description:
Motivationally-enhanced cognitive behavioral skills counseling
Treatment:
Behavioral: MI-CBT
Brief Advice
Active Comparator group
Description:
Advice and education
Treatment:
Behavioral: Brief Advice

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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