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 range18 Years – 49 Years

SexFEMALE

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

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 range18 Years – 49 Years

SexFEMALE

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))