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

Primary Purpose

Alcohol Abuse, Cocaine Abuse, Marijuana Abuse

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MI-CBT
Brief Advice
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept 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. -

Sites / Locations

  • Bridgeport Hospital
  • Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MI-CBT

Brief Advice

Arm Description

Motivationally-enhanced cognitive behavioral skills counseling

Advice and education

Outcomes

Primary Outcome Measures

Percentage of Days Used Drugs or Alcohol
Percentage of Days Used Drugs or Alcohol
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

Secondary Outcome Measures

Incidence of Preterm Births
Incidence of Low Birth Weight
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
Proportion of Participants Abstinent From Drugs According to Urine
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
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
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
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
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
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
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.
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.
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.
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.
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.
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
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
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

Full Information

First Posted
September 27, 2005
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00227903
Brief Title
Therapeutic Substance Abuse Treatment in Pregnancy - 1
Acronym
PRIDE-P
Official Title
Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Cocaine Abuse, Marijuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MI-CBT
Arm Type
Experimental
Arm Description
Motivationally-enhanced cognitive behavioral skills counseling
Arm Title
Brief Advice
Arm Type
Active Comparator
Arm Description
Advice and education
Intervention Type
Behavioral
Intervention Name(s)
MI-CBT
Intervention Description
Motivationally-enhanced cognitive behavioral skills counseling
Intervention Type
Behavioral
Intervention Name(s)
Brief Advice
Intervention Description
Advice and education
Primary Outcome Measure Information:
Title
Percentage of Days Used Drugs or Alcohol
Time Frame
intake to delivery, an average of 21 weeks
Title
Percentage of Days Used Drugs or Alcohol
Time Frame
delivery to 3 months post-delivery
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
Incidence of Preterm Births
Time Frame
At delivery
Title
Incidence of Low Birth Weight
Time Frame
At delivery
Title
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
Title
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
Title
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
Title
Proportion of Participants Abstinent From Drugs According to Urine
Description
Based on urine tests for marijuana, cocaine, or opioids
Time Frame
Delivery to 3 months post-delivery
Title
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
intake to delivery, an average of 21 weeks
Title
Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
Description
Based on urine tests for marijuana, cocaine, or opioids.
Time Frame
Delivery to 3 months post-delivery
Title
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
Title
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
Title
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
Title
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
Title
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
intake to delivery, an average of 21 weeks
Title
Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
Delivery to 3 months post-delivery
Title
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
intake to delivery, an average of 21 weeks
Title
Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
Delivery to 3 months post-delivery
Title
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
Description
Based on urine tests for marijuana, cocaine or opioids.
Time Frame
intake to delivery, an average of 21 weeks
Title
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
Description
Based on urine tests for marijuana, cocaine or opioids
Time Frame
Delivery to 3 months post-delivery
Title
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
Description
Based on urine tests for marijuana, cocaine or opioids
Time Frame
intake to delivery, an average of 21 weeks
Title
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
Description
Based on urine tests for marijuana, cocaine or opioids
Time Frame
Delivery to 3 months post-delivery
Other Pre-specified Outcome Measures:
Title
Adequacy of Received Services
Description
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.
Time Frame
After prenatal care initiation
Title
Attendance of Treatment Outside the Study
Description
The number of patients who attended outside treatment in the 30 days prior to each assessment.
Time Frame
30 days prior to assessment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
only aggregate de-identified data
Citations:
PubMed Identifier
19350369
Citation
Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.
Results Reference
background
PubMed Identifier
18956504
Citation
Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244.
Results Reference
background
PubMed Identifier
20859145
Citation
Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.
Results Reference
background
PubMed Identifier
22489543
Citation
Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.
Results Reference
background
PubMed Identifier
22795046
Citation
Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.
Results Reference
result
PubMed Identifier
28270105
Citation
Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.
Results Reference
derived
PubMed Identifier
24447885
Citation
Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.
Results Reference
derived

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Therapeutic Substance Abuse Treatment in Pregnancy - 1

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