Financial Incentives for Smoking Cessation Among Mothers

NCT05740098 | Completed Results

• 2 other identifiers: 5R01HD078332R01HD078332
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.

Conditions

Cigarette Smoking

Keywords

Cigarette Smoking; Quit Smoking; Mothers

Outcome Measures

Primary Outcomes (2)

• 7-day Point Prevalence Smoking Abstinence Levels

  Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.

  Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms

• Objective Measure of Child Secondhand Smoke Exposure (SHSe)

  SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.

  Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date

Secondary Outcomes (4)

• Continuous Abstinence

  24 weeks following quit date

• 7-day Point Prevalence Abstinence at 48-week Follow-up Assessment

  48 weeks following quit date

• Smoking Abstinence

  Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date.

• Smoking Abstinence

  Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.

Other Outcomes (4)

• Number of Outpatient Child Visits to Healthcare Center.

  48 weeks following quit date.

• Number of Inpatient Child Visits to Healthcare Center.

  48 weeks following quit date.

• Number of Times Child Received Prescription Medications.

  48 weeks following quit date.

Study Arms (3)

Best practices

EXPERIMENTAL

Participants will receive the Five As plus a referral to a quit line.

Behavioral: Best Practices

Best practices and financial incentives

EXPERIMENTAL

Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence

Behavioral: Best Practices; Behavioral: Financial Incentives

Best practices, financial incentives, and NRT

EXPERIMENTAL

Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy.

Behavioral: Best Practices; Behavioral: Financial Incentives; Drug: Nicotine Replacement Therapy

Interventions

Best Practices BEHAVIORAL

Five As plus referral to a quit line

Also known as: Usual Care

Best practices; Best practices and financial incentives; Best practices, financial incentives, and NRT

Financial Incentives BEHAVIORAL

Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.

Also known as: Contingency Management

Best practices and financial incentives; Best practices, financial incentives, and NRT

Nicotine Replacement Therapy DRUG

Nicotine patches and gum/lozenge provided together for dual therapy

Also known as: NRT

Best practices, financial incentives, and NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Expresses interest in quitting smoking
• Express willingness to initiate NRT
• Mother is ≥ 18 years of age
• Self-reported smoking ≥ 10 cigarettes per day for ≥ 1 year, biochemically verified
• Mother has a child \< 12 years of age
• Child resides with mother full-time
• Not currently using any other tobacco cessation medications (e.g. Chantix) or NRT, or willing to stop use prior to participation in the study
• Lives in Chittenden County, Vermont or surrounding counties
• Plans on remaining in the geographical area for the next 12 months
• English-speaking
• Willing to let child participate in the study

You may not qualify if:

• Failing to meet any of the above criteria
• Has medical contraindications to NRT products
• Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed)
• Current/past psychotic disorder
• Being suicidal
• Currently pregnant or trying to become pregnant in the next 12 months
• Incarceration
• Refusal to participate in study

Sponsors & Collaborators

• University of Vermont: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Higgins ST, Plucinski S, Orr E, Nighbor TD, Coleman SRM, Skelly J, DeSarno M, Bunn J. Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure. Prev Med. 2023 Nov;176:107651. doi: 10.1016/j.ypmed.2023.107651. Epub 2023 Jul 30.

  PMID: 37527730 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Practice Guidelines as Topic; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Stephen T. Higgins, PhD., P.I.
• Organization: University of Vermont

stephen.higgins@uvm.edu

802-656-9615

Study Officials

• Stephen T Higgins, PhD

  University of Vermont

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Vermont Center on Behavior and Health and Vice Chair of Department of Psychiatry

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: February 22, 2023
• Study Start: June 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: October 1, 2020
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)