Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tobacco Intervention
Participants in this group will be randomized to the Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC) intervention.
  • Behavioral: Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC)
    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).
Active Comparator
Treatment As Usual
Participants in this group will be randomized to tobacco treatment as usual.
  • Behavioral: Treatment As Usual
    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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky Polk Dalton Clinic
Lexington, Kentucky 40536
Contact:
Andrea McCubbin
859-323-6650
akmccu0@uky.edu

Baptist Health Lexington
Lexington, Kentucky 40503
Contact:
Janine Barnett, MSN
859-667-2230
jmzabr0@uky.edu

More Details

NCT ID
NCT03796208
Status
Recruiting
Sponsor
Kristin Ashford

Study Contact

Andrea McCubbin
859-323-6650
akmccu0@uky.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.