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Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University Identifier:
First received: July 5, 2007
Last updated: March 1, 2013
Last verified: March 2013
The primary objective of the proposed study is to evaluate the efficacy of tobacco abstinence-contingent voucher incentives versus non-tobacco abstinence-contingent incentives for reducing or eliminating tobacco use during pregnancy in methadone treated women. In addition, the impact that this intervention has in reducing the incidence and severity of methadone associated neonatal abstinence syndrome will also be examined.

Condition Intervention Phase
Nicotine Dependence Behavioral: tobacco abstinent contingent Behavioral: non-contingent Behavioral: control Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Use in Opioid Agonist Treated Pregnant Women

Further study details as provided by Hendree E. Jones, Johns Hopkins University:

Primary Outcome Measures:
  • Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score [ Time Frame: from treatment entry until 6 weeks post-partum ]

Secondary Outcome Measures:
  • tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters [ Time Frame: from treatment entry to 6 weeks posrt-partum ]

Estimated Enrollment: 210
Study Start Date: January 2005
Study Completion Date: June 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tobacco abstinent contingent voucher
Tobacco abstinent contingent voucher condition
Behavioral: tobacco abstinent contingent
Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
Experimental: non-contingent
Participants receive vouchers non-contingent upon tobacco use status
Behavioral: non-contingent
Participants receive vouchers regardless of tobacco use status
no voucher
This is the standard care intervention
Behavioral: control
this group receives no vouchers


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed pregnancy
  • Treatment entry at or before 31 weeks EGA
  • Expected to enter drug-free outpatient modality at CAP
  • Placed on methadone pharmacotherapy
  • Nicotine dependent
  • Sufficient literacy and understanding for assessment procedures
  • Expected availability for study duration (e.g., complete inpatient stay)
  • Able and willing to provide informed consent
  • At least 18 years of age
  • Confirmed smoker of 10 or more cigarettes

Exclusion Criteria:

  • Not pregnant
  • EGA of 32 weeks or greater
  • 17 years of age or younger
  • Undergoing detoxification (non-methadone treatment)
  • Unable to provide informed consent
  • Currently receiving nicotine replacement products (NRT)
  • Current diagnosis of alcohol or benzodiazepine dependence
  • Severe medical or psychiatric concomitant conditions that would interfere with treatment or require extended hospitalization.
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Please refer to this study by its identifier: NCT00497068

United States, Maryland
Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hendree E. Jones, Adjunct Professor, Johns Hopkins University Identifier: NCT00497068     History of Changes
Other Study ID Numbers: R01DA012403 ( U.S. NIH Grant/Contract )
Study First Received: July 5, 2007
Last Updated: March 1, 2013

Keywords provided by Hendree E. Jones, Johns Hopkins University:
neonatal abstinence syndrome

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders processed this record on September 21, 2017