CompletedNot Applicable

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

United States78 participantsStarted 2018-12-12

Plain-language 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.

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Current diagnosis of opioid dependence with participation in the University of Kentucky Healthcare and Baptist Health Lexington buprenorphine treatment program * Less than 24 weeks gestation * Age 18-49 years old * Diagnosis of current tobacco use disorder * Read or write in English Exclusion Criteria: * Current prisoner status * Current severe mental illness (e.g., bipolar disorder with current mania, current suicidal ideation) * Alcohol or sedative/hypnotic dependence that requires medical intervention

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the Number of Cigarettes Smoked Per Day

Timeframe: up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Urine Cotinine Concentration Level

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Electronic Cigarette Usage Per Day

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Cigarette Dependence

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))

Change in Electronic Cigarette Dependence

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Trial details

NCT IDNCT03796208

SponsorKristin Ashford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-24

Results submitted2022-05-19

View on ClinicalTrials.gov More Smoking Cessation trials

Plain-language summary

Who can participate

Age range

18 Years – 49 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in the Number of Cigarettes Smoked Per Day

Timeframe: up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Urine Cotinine Concentration Level

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Electronic Cigarette Usage Per Day

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Change in Cigarette Dependence

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))

Change in Electronic Cigarette Dependence

Timeframe: up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))