Tobacco Use in Opioid Agonist Treated Pregnant Women

Study Overview
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Brief Summary
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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.

Official Title
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Tobacco Use in Opioid Agonist Treated Pregnant Women

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Behavioral: tobacco abstinent contingent
* Behavioral: non-contingent
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tobacco abstinent contingent voucher<br>Tobacco abstinent contingent voucher condition | Behavioral: tobacco abstinent contingent<br>* Participants receive vouchers wiht monetary rewards for providing breath samples that show tobacco smoking abstinence<br>|
| Experimental: non-contingent<br>Participants receive vouchers non-contingent upon tobacco use status | Behavioral: non-contingent<br>* Participants receive vouchers regardless of tobacco use status<br>|
| Other: no voucher<br>This is the standard care intervention | Behavioral: control<br>* this group receives no vouchers<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, pregnancy, neonatal abstinence syndrome