Reinforcement-Based Treatment for Pregnant Drug Abusers (HOME II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by National Institute on Drug Abuse (NIDA)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Hendree E. Jones, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01177982
First received: August 6, 2010
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

Objectives: This project is a Stage II behavioral development study designed to answer remaining critical questions necessary before disseminating Reinforcement Based Treatment(RBT) to the larger treatment community. These questions focus on the levels of intensity of RBT most efficacious for drug-addicted pregnant patients, whether the outcomes achieved with women not receiving methadone will be similar when methadone-maintained patients are included, the individual mediators and moderators that determine which RBT treatment level is best for which patient, and the cost-effectiveness of RBT treatment. Design: The proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (SMART) design. Participants (N=300) will first be randomized at treatment outset into either treatment-as-usual RBT or a reduced intensity RBT. All participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. Early-non-compliant participants will be randomized to receive either the same or an increased level of RBT treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. Primary outcome measures include treatment completion and maternal heroin and cocaine use. Secondary outcome measures include maternal measures of HIV risk behavior, other drug use, and psychosocial functioning and neonatal measures of length of hospitalization, physical birth parameters, neurological integrity, and behavioral functioning. Innovation and Significance: The proposed project's innovation includes: the novelty RBT, use of a cutting-edge SMART model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. The proposed project's significance is exceedingly high, as it will lay the foundation for later Stage III studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.


Condition Intervention Phase
Drug Use Disorders During Pregnancy
Behavioral: Usual RBT
Behavioral: Lite RBT
Behavioral: Less RBT
Behavioral: Intense RBT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reinforcement-Based Treatment for Pregnant Drug Abusers

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Treatment Completion [ Time Frame: delivery ] [ Designated as safety issue: No ]
    Delivering a baby, regardless of delivery hospital, while enrolled in treatment.

  • drug use [ Time Frame: during and post-treatment ] [ Designated as safety issue: Yes ]
    Drug Use: Self-reported drug use of heroin and cocaine will be collected monthly with the ASI. Self-report will be verified by urine drug screening.


Secondary Outcome Measures:
  • urine testing [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
    Urines will be tested immediately using a rapid test for cocaine and opiate metabolites.Urines are tested daily for 2 weeks. From two weeks until study delivery, urine samples will be collected twice a week .

  • Alcohol [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
    Each time a urine sample is collected, a breathalyzer reading will also be obtained

  • Maternal Weight Gain [ Time Frame: baseline, during and post-treatment ] [ Designated as safety issue: Yes ]
    Assessed at every prenatal visit. Change from CAP admission controlled for gestational age at admission will be calculated. Weight is collected as a measure of maternal health.

  • Maternal Obstetrical Course/Outcome [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
    These data will be abstracted from the completed delivery record (e.g., Number of OB visits, maternal urine toxicology results at delivery, complications during labor/delivery, placental abruption, and type of delivery, maternal length of hospital stay, length of labor, use of pain medication).

  • Physical Birth Parameters [ Time Frame: delivery and postnatal ] [ Designated as safety issue: Yes ]
    Initial birth weight, head circumference, and length provide measures of neonatal well-being and health. Thus, this information will be abstracted from medical records.

  • Length of Hospital Stay [ Time Frame: postnatal ] [ Designated as safety issue: Yes ]
    Length of hospital stay is an indicator of health and well-being. The total days in the Newborn Nursery, Pediatrics and Neonatal Intensive Care will be abstracted from the medical records.

  • APGAR scores [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
    Scores are assigned to every infant after birth at 1 and 5 minutes, and if compromised, at 10 and 20 minutes.


Estimated Enrollment: 300
Study Start Date: July 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lite RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
Behavioral: Lite RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
Behavioral: Less RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Recreation
Experimental: Usual RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
Behavioral: Usual RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
Behavioral: Intense RBT
Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing ALU admission Recovery sponsor

  Eligibility

Ages Eligible for Study:   18 Years to 46 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1 Treatment entry at or before 32 weeks EGA with singleton fetus. 3) Evidence of cocaine and/or opiate use.

4) Completion of the residential detoxification stay.

Exclusion Criteria:

  1. Severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization.
  2. Age 17 years or younger.
  3. Geographical constraints. These women are admitted only for a residential detoxification and often have plans to obtain aftercare in an outpatient or residential facility in closer proximity to their home. Thus, this greater distance from CAP increases the likelihood that these women will not return to CAP and will not deliver in a hospital that functions under similar protocols that operate in Baltimore City for treating drug-exposed neonates.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177982

Contacts
Contact: Michelle Tuten, LCSW 410-550-5700 mtuten@jhmi.edu
Contact: Heather Fitzsimons 410-550-7680 hfitzsim@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Michelle Tuten    410-550-5700    mtuten@jhmi.edu   
Contact: Heather Fitzsimons    410-550-7680    hfitzsim@jhmi.edu   
Principal Investigator: Hendree E Jones, PhD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Margaret Chisolm, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Hendree E. Jones, Adjunct Professor, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01177982     History of Changes
Other Study ID Numbers: DA14979-06, R01DA014979, DCNBR
Study First Received: August 6, 2010
Last Updated: October 19, 2012
Health Authority: United States: Federal Government
United States:IRB-JHU

Keywords provided by National Institute on Drug Abuse (NIDA):
pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014