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Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00497068
First received: July 5, 2007
Last updated: March 1, 2013
Last verified: March 2013

July 5, 2007
March 1, 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 ] [ Designated as safety issue: No ]
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score [ Time Frame: from treatment entry until 6 weeks post-partum ]
Complete list of historical versions of study NCT00497068 on ClinicalTrials.gov Archive Site
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters [ Time Frame: from treatment entry to 6 weeks posrt-partum ] [ Designated as safety issue: No ]
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters [ Time Frame: from treatment entry to 6 weeks posrt-partum ]
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00497068
R01 DA 12403, R01DA012403, R01 DA012403, DPMCDA
No
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