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OpenTrials
Completed

NCT Number: NCT00497068

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.

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Key information

Conditions

Nicotine Dependence Behavior Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Mental Disorders Neonatal Abstinence Syndrome Smoking Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tobacco abstinent contingent

Behavioral

Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence

non-contingent

Behavioral

Participants receive vouchers regardless of tobacco use status

Control

Behavioral

this group receives no vouchers

Primary outcomes

  1. Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score

    Time frame: from treatment entry until 6 weeks post-partum

Secondary outcomes

  1. tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters

    Time frame: from treatment entry to 6 weeks posrt-partum

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: ROSE

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Jul 6, 2007
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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