Clinical trial NCT03796208: Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
Official title: Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC): Reducing Tobacco Use Among Opioid Addicted Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Opioid Use Disorder
Pregnancy
tobacco
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-01-08
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will use a prospective, 2-group, randomized, comparative effectiveness design to determine if the B-EPIC tobacco intervention is superior to tobacco 'treatment as usual (TAU)' for opioid dependent pregnant women maintained on buprenorphine; the outcomes for the first aim will be quitting smoking and/or reducing cigarette consumption during pregnancy. The project design also will determine the economic impact the B-EPIC intervention (10-months) has on healthcare expenditures.

After informed consent, eligible participants will be randomized (1:1) to the B-EPIC group (tobacco intervention) or TAU tobacco treatment (control group). All will continue to receive opioid dependence treatment with buprenorphine, regardless of treatment assignment.

Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the American College of Obstetricians and Gynecologists (ACOG) 5'A's approach by their healthcare provider. This standard tobacco cessation counseling takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment.

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. The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. The intervention will be led by a certified tobacco treatment specialist (CTTS).

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

Primary outcomes:
measure: 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))
measure: 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))
measure: 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))
measure: 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))
measure: 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))
Secondary outcomes:
measure: Change in Maternal Depression Over Time
timeFrame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
measure: Change in Maternal Anxiety Over Time
timeFrame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
measure: Change in Maternal Perceived Stress Over Time
timeFrame: Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Polk Dalton Clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kristin Ashford
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Amanda Fallin-Bennett
role: PRINCIPAL_INVESTIGATOR
References: