CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03796208
NCT03796208N/ACompleted

Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women

Kristin Ashford·interventional·Posted Jan 8, 2019·Updated Jul 15, 2022

In Brief

A clinical study evaluating Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) and Treatment As Usual for Smoking Cessation. Completed, enrolled 78 participants across 2 sites.

Detailed Summary

This study tests an intervention for tobacco cessation (named B-EPIC) in an established community medication assisted treatment (MAT) clinic for pregnant and postpartum women with opioid dependence. Half of the participants will receive the intervention for tobacco cessation, which is standard cessation counseling from the provider plus additional cessation support from a Certified Tobacco Treatment Specialist (CTTS). The other half of participants will receive standard tobacco cessation from their provider. The project will also determine the economic impact of the B-EPIC intervention on healthcare expenditures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 8, 2019
Enrollment StartDec 12, 2018
Primary CompletionMay 24, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.5 years ago

Interventions

Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC)behavioral

Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).

Treatment As Usualbehavioral

Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.