Therapeutic Substance Abuse Treatment in Pregnancy - 1

Study Overview
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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).

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.

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

Conditions
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Alcohol Abuse, Cocaine Abuse, Marijuana Abuse

Intervention / Treatment
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* Behavioral: MI-CBT
* Behavioral: Brief Advice


Participation Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MI-CBT<br>Motivationally-enhanced cognitive behavioral skills counseling | Behavioral: MI-CBT<br>* Motivationally-enhanced cognitive behavioral skills counseling<br>|
| Active Comparator: Brief Advice<br>Advice and education | Behavioral: Brief Advice<br>* Advice and education<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Days Used Drugs or Alcohol |  | intake to delivery, an average of 21 weeks | 
| 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 |  | intake to delivery, an average of 21 weeks | 
| 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 |  | intake to delivery, an average of 21 weeks | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | intake to delivery, an average of 21 weeks | 
| 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 | Based on urine tests for marijuana, cocaine, or opioids | Delivery to 3 months post-delivery | 
| Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks | 
| Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine | Based on urine tests for marijuana, cocaine, or opioids. | Delivery to 3 months post-delivery | 
| 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 |  | intake to delivery, an average of 21 weeks | 
| 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 |  | intake to delivery, an average of 21 weeks | 
| 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 | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks | 
| Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | Delivery to 3 months post-delivery | 
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks | 
| Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine | Based on urine tests for marijuana, cocaine or opioids. | Delivery to 3 months post-delivery | 
| 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 | Based on urine tests for marijuana, cocaine or opioids. | intake to delivery, an average of 21 weeks | 
| 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 | Based on urine tests for marijuana, cocaine or opioids | Delivery to 3 months post-delivery | 
| 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 | Based on urine tests for marijuana, cocaine or opioids | intake to delivery, an average of 21 weeks | 
| 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 | Based on urine tests for marijuana, cocaine or opioids | Delivery to 3 months post-delivery |