Tobacco Use in Opioid Agonist Treated Pregnant Women - Full Text View

Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), May 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00497068

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: contingency management	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Tobacco Use in Opioid Agonist Treated Pregnant Women

Further study details as provided by National Institute on Drug Abuse (NIDA):

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
Estimated Study Completion Date:	July 2009

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

Contacts


Contact: Michelle Tuten, MSW	410-550-5700	mtuten@jhmi.edu

Contact: Heather Fitzsimons, MA	410-550-1813	hfitzsim@jhmi.edu

Locations


United States, Maryland
	Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy	Recruiting
	Baltimore, Maryland, United States, 21224
	Principal Investigator: Hendree E Jones, PhD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Hendree E Jones, PhD	Johns Hopkins University

More Information

Study ID Numbers:	R01 DA 12403
First Received:	July 5, 2007
Last Updated:	May 27, 2008
ClinicalTrials.gov Identifier:	NCT00497068
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

smoking

pregnancy

neonatal abstinence syndrome

Study placed in the following topic categories:

Smoking

Mental Disorders

Neonatal Abstinence Syndrome

Tobacco Use Disorder

Substance-Related Disorders

Disorders of Environmental Origin

ClinicalTrials.gov processed this record on October 06, 2008