Tobacco Use in Opioid Agonist Treated Pregnant Women (ROSE)

Johns Hopkins University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Nicotine Dependence

Treatments: Behavioral: non-contingent; Behavioral: control; Behavioral: tobacco abstinent contingent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00497068

DPMCDA

R01DA012403 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

tobacco abstinent contingent voucher

Experimental group

Description:

Tobacco abstinent contingent voucher condition

Treatment:

Behavioral: tobacco abstinent contingent

non-contingent

Experimental group

Description:

Participants receive vouchers non-contingent upon tobacco use status

Treatment:

Behavioral: non-contingent

no voucher

Other group

Description:

This is the standard care intervention

Treatment:

Behavioral: control