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

NCT03796208 | Completed Results

• 2 other identifiers: 450621R34DA046005-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Smoking Cessation

Keywords

Opioid Use Disorder; Pregnancy; tobacco

Outcome Measures

Primary Outcomes (5)

• Change in the Number of Cigarettes Smoked Per Day

  Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups.

  up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

• Change in Urine Cotinine Concentration Level

  Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups.

  up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

• Change in Electronic Cigarette Usage Per Day

  Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups.

  up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

• Change in Cigarette Dependence

  Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups.

  up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery))

• Change in Electronic Cigarette Dependence

  Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups.

  up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Secondary Outcomes (3)

• Change in Maternal Depression Over Time

  Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

• Change in Maternal Anxiety Over Time

  Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

• Change in Maternal Perceived Stress Over Time

  Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery))

Study Arms (2)

Tobacco Intervention

EXPERIMENTAL

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)

Treatment As Usual

ACTIVE COMPARATOR

Participants in this group will be randomized to tobacco treatment as usual.

Behavioral: Treatment As Usual

Interventions

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

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).

Tobacco Intervention

Treatment As Usual BEHAVIORAL

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.

Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: All participants in this study will be pregnant females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kristin Ashford: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

University of Kentucky Polk Dalton Clinic

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

The B-EPIC study was significantly impacted by the COVID-19 pandemic in terms of recruitment, overall enrollment, and the ability to collect longitudinal data. In spite of the challenges, we were able to enroll 76% of the proposed number of participants in each group. However, power was estimated based on a sample size of 50 per group, and some group comparisons may not have reached significance due to a more limited power given the smaller sample size.

Results Point of Contact

• Title: Kristin Ashford, PhD, Study MPI
• Organization: University of Kentucky

khashf0@uky.edu

859-257-9333

Study Officials

• Kristin Ashford

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Amanda Fallin-Bennett

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Dean of Undergraduate Faculty Affairs

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: December 12, 2018
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: July 15, 2022
• Results First Posted: July 15, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)