Therapeutic Substance Abuse Treatment in Pregnancy - 1

Alcohol Abuse Clinical Trial

— PRIDE-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227903
• Other study ID #: 0402026466
• Secondary ID: R01DA019135
• Status: Completed
• Phase: Phase 2
• Start date: September 2004
• Est. completion date: August 2010

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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.

-

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Cocaine Abuse
• Cocaine-Related Disorders
• Marijuana Abuse

Intervention

Behavioral:
• MI-CBT
Motivationally-enhanced cognitive behavioral skills counseling
• Brief Advice
Advice and education

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View 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. — View 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 — View 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):827-33. doi: 10.1097/AOG.0b013e3181ed8290. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adequacy of Received Services	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.	After prenatal care initiation
Other	Attendance of Treatment Outside the Study	The number of patients who attended outside treatment in the 30 days prior to each assessment.	30 days prior to assessment
Primary	Percentage of Days Used Drugs or Alcohol		intake to delivery, an average of 21 weeks
Primary	Percentage of Days Used Drugs or Alcohol		delivery to 3 months post-delivery
Primary	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
Primary	Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol		Delivery to 3 months post-delivery
Primary	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
Primary	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	Incidence of Preterm Births		At delivery
Secondary	Incidence of Low Birth Weight		At delivery
Secondary	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
Secondary	Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report		Delivery to 3 months post-delivery
Secondary	Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine		intake to delivery, an average of 21 weeks
Secondary	Proportion of Participants Abstinent From Drugs According to Urine	Based on urine tests for marijuana, cocaine, or opioids	Delivery to 3 months post-delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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