Tobacco Use in Opioid Agonist Treated Pregnant Women

Johns Hopkins University210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Nicotine Dependence

Interventions

tobacco abstinent contingentBEHAVIORAL

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

non-contingentBEHAVIORAL

Participants receive vouchers regardless of tobacco use status

controlBEHAVIORAL

this group receives no vouchers

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins Bayview Medical Center, Center for Addiction and Pregnancy

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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