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

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).
    

Intervention name(s): Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC); Treatment As Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).; Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Use Disorder; Pregnancy; tobacco