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Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00497068
First Posted: July 6, 2007
Last Update Posted: March 5, 2013
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Hendree E. Jones, Johns Hopkins University
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497068


Locations
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)
Investigators
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hendree E. Jones, Adjunct Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00497068     History of Changes
Other Study ID Numbers: R01DA012403 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: July 5, 2007
First Posted: July 6, 2007
Last Update Posted: March 5, 2013
Last Verified: March 2013

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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders