Clinical trial NCT00227903: Therapeutic Substance Abuse Treatment in Pregnancy - 1
Official title: Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Abuse
Cocaine Abuse
Marijuana Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-28
Enrollment: 168
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

-

Primary outcomes:
measure: Percentage of Days Used Drugs or Alcohol
timeFrame: intake to delivery, an average of 21 weeks
measure: Percentage of Days Used Drugs or Alcohol
timeFrame: delivery to 3 months post-delivery
measure: Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
timeFrame: intake to delivery, an average of 21 weeks
measure: Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
timeFrame: Delivery to 3 months post-delivery
measure: Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
timeFrame: intake to delivery, an average of 21 weeks
measure: Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol
timeFrame: Delivery to 3 months post-delivery
Secondary outcomes:
measure: Incidence of Preterm Births
timeFrame: At delivery
measure: Incidence of Low Birth Weight
timeFrame: At delivery
measure: Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
timeFrame: intake to delivery, an average of 21 weeks
measure: Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report
timeFrame: Delivery to 3 months post-delivery
measure: Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine
timeFrame: intake to delivery, an average of 21 weeks
measure: Proportion of Participants Abstinent From Drugs According to Urine
timeFrame: Delivery to 3 months post-delivery
measure: Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
timeFrame: intake to delivery, an average of 21 weeks
measure: Proportion of Participants Abstinent From Both Drugs and Alcohol According to Combined Self-report and Urine
timeFrame: Delivery to 3 months post-delivery
measure: 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
timeFrame: intake to delivery, an average of 21 weeks
measure: 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
timeFrame: Delivery to 3 months post-delivery
measure: 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
timeFrame: intake to delivery, an average of 21 weeks
measure: 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
timeFrame: Delivery to 3 months post-delivery
measure: Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
timeFrame: intake to delivery, an average of 21 weeks
measure: Proportion of Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
timeFrame: Delivery to 3 months post-delivery
measure: Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
timeFrame: intake to delivery, an average of 21 weeks
measure: Proportion of Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Abstinent From Drugs According to Urine
timeFrame: Delivery to 3 months post-delivery
measure: 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
timeFrame: intake to delivery, an average of 21 weeks
measure: 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
timeFrame: Delivery to 3 months post-delivery
measure: 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
timeFrame: intake to delivery, an average of 21 weeks
measure: 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
timeFrame: Delivery to 3 months post-delivery
Other outcomes:
measure: Adequacy of Received Services
timeFrame: After prenatal care initiation
measure: Attendance of Treatment Outside the Study
timeFrame: 30 days prior to assessment
Locations:
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly A Yonkers, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.