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

Kristin Ashford

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: Treatment As Usual

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03796208

1R34DA046005-01 (U.S. NIH Grant/Contract)

45062

Details and patient eligibility

About

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.

Full 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).

Enrollment

78 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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