Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497068
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : March 5, 2013
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University

July 5, 2007
July 6, 2007
March 5, 2013
January 2005
September 2009   (Final data collection date for primary outcome measure)
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score [ Time Frame: from treatment entry until 6 weeks post-partum ]
Same as current
Complete list of historical versions of study NCT00497068 on Archive Site
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters [ Time Frame: from treatment entry to 6 weeks posrt-partum ]
Same as current
Not Provided
Not Provided
Tobacco Use in Opioid Agonist Treated Pregnant Women
Tobacco Use in Opioid Agonist Treated Pregnant Women
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nicotine Dependence
  • Behavioral: tobacco abstinent contingent
    Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence
  • Behavioral: non-contingent
    Participants receive vouchers regardless of tobacco use status
  • Behavioral: control
    this group receives no vouchers
  • Experimental: tobacco abstinent contingent voucher
    Tobacco abstinent contingent voucher condition
    Intervention: Behavioral: tobacco abstinent contingent
  • Experimental: non-contingent
    Participants receive vouchers non-contingent upon tobacco use status
    Intervention: Behavioral: non-contingent
  • no voucher
    This is the standard care intervention
    Intervention: Behavioral: control
Tuten M, Svikis DS, Keyser-Marcus L, O'Grady KE, Jones HE. Lessons learned from a randomized trial of fixed and escalating contingency management schedules in opioid-dependent pregnant women. Am J Drug Alcohol Abuse. 2012 Jul;38(4):286-92. doi: 10.3109/00952990.2011.643977. Epub 2012 Feb 22.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2010
September 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01DA012403( U.S. NIH Grant/Contract )
R01DA012403 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Hendree E. Jones, Johns Hopkins University
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
Johns Hopkins University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP