Tobacco Use in Opioid Agonist Treated Pregnant Women

Phase 2

Completed

• Conditions: Nicotine Dependence
• Interventions: Behavioral: non-contingent; Behavioral: control; Behavioral: tobacco abstinent contingent

• Registration Number: NCT00497068
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2007-07-05
• Study First Submitted QC: 2007-07-05
• Study First Posted: 2007-07-06
• Primary Completion: 2009-09
• Study Completion: 2010-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-contingent	non-contingent	Participants receive vouchers non-contingent upon tobacco use status
no voucher	control	This is the standard care intervention
tobacco abstinent contingent voucher	tobacco abstinent contingent	Tobacco abstinent contingent voucher condition

Primary Outcome Measures

Name	Time	Method
Percent of tobacco-free urine samples submitted and Neonatal Abstinence Score	from treatment entry until 6 weeks post-partum

Secondary Outcome Measures

Name	Time	Method
tobacco use measures • treatment compliance• Neonatal measures include:Birth parameters	from treatment entry to 6 weeks posrt-partum

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy; 🇺🇸 Baltimore, Maryland, United States