N/A
N=78
Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT03796208 ↗Enrolled (actual)
78
Serious AEs
15.8%
Results posted
Jul 2022
Primary outcome: Primary: Change in the Number of Cigarettes Smoked Per Day — 0; 0 cigarettes per day
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) (Behavioral); Treatment As Usual (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kristin Ashford
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Cigarettes Smoked Per Day |
0; 0 | — |
| PRIMARY Change in Urine Cotinine Concentration Level |
-0.09; 0.17 | — |
| PRIMARY Change in Electronic Cigarette Usage Per Day |
1; -6 | — |
| PRIMARY Change in Cigarette Dependence |
2.04; 1.42 | — |
| PRIMARY Change in Electronic Cigarette Dependence |
-5.0; -1.5 | — |
| SECONDARY Change in Maternal Depression Over Time |
2.42; 2.58 | — |
| SECONDARY Change in Maternal Anxiety Over Time |
2.0; 1.52 | — |
| SECONDARY Change in Maternal Perceived Stress Over Time |
0.73; 1.04 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03796208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.