Tobacco Use in Opioid Agonist Treated Pregnant Women

Johns Hopkins University1 site in 1 country210 target enrollmentJanuary 2005

ConditionsNicotine Dependence

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Nicotine Dependence
Sponsor: Johns Hopkins University
Enrollment: 210
Locations: 1
Primary Endpoint: Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

June 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Principal Investigator

Hendree E. Jones

Adjunct Professor

Johns Hopkins University

Eligibility 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.