Tobacco Use in Opioid Agonist Treated Pregnant Women

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00497068

Acronym

ROSE

Enrollment

210

Registered

2007-07-06

Start date

2005-01-31

Completion date

2010-06-30

Last updated

2013-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

smoking, pregnancy, neonatal abstinence syndrome

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.

Interventions

BEHAVIORALtobacco abstinent contingent

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

BEHAVIORALnon-contingent

Participants receive vouchers regardless of tobacco use status

BEHAVIORALcontrol

this group receives no vouchers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026