Trial record 10 of 377 for:    (tobacco OR smoking) AND (woman OR women OR female OR maternal OR pregnan)

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobacco Use in Opioid Agonist Treated Pregnant Women

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Hendree E Jones, PhD Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional 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: R01 DA 12403, R01DA012403, R01 DA012403, DPMCDA
Study First Received: July 5, 2007
Last Updated: March 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
smoking
pregnancy
neonatal abstinence syndrome

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 17, 2014