Small Financial Incentives to Promote Smoking Cessation

NCT02737566 | Completed Results

• 2 other identifiers: 6260R01CA197314
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are 1) to evaluate the longer-term impact of an adjunctive, low-cost financial incentives intervention (relative to standard care) on smoking abstinence rates among socioeconomically disadvantaged individuals participating in a clinic-based smoking cessation program and 2) to identify treatment mechanisms and contextual factors associated with cessation outcomes among intervention participants using both traditional and ecological momentary assessment approaches. Those randomized to the financial incentives intervention will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. We hypothesize that individuals who are randomly assigned to the adjunctive CM intervention will have significantly higher rates of biochemically-verified abstinence at the 26-week post-quit follow-up than those assigned to Usual Care. In addition, we hypothesize that several factors related to socioeconomic disadvantage will be directly associated with non-abstinence, especially greater stress/adversity, limited psychosocial resources, greater negative affect, greater nicotine dependence, and poorer treatment adherence. The primary study endpoints will include self-reported tobacco use/abstinence, expired carbon monoxide (CO) levels (i.e., the amount of carbon monoxide present in an individual's breath when they breathe out), and saliva cotinine levels at 26 weeks post-quit attempt, though smoking status will be assessed at all visits. Traditional questionnaire measurement and ecological momentary assessment (EMA) will be utilized to measure potential treatment mechanisms including motivation, self-efficacy, and treatment adherence. Other variables including stress/adversity, psychosocial resources, negative affect, nicotine dependence, and treatment adherence will also be assessed.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Financial Incentives; Contingency Management; Vulnerable Populations; Medically Uninsured; Medicaid

Outcome Measures

Primary Outcomes (1)

• Biochemically-verified Smoking Cessation

  The primary outcome measure is carbon monoxide (CO)-verified 7-day point prevalence abstinence at 26 weeks post-quit (intent-to-treat; missing=smoking).

  26 weeks post-quit

Secondary Outcomes (1)

• Biochemically-verified Smoking Cessation

  12 weeks post-quit

Study Arms (2)

Standard Care + Financial Incentives

EXPERIMENTAL

Participants randomized to Standard Care + Financial Incentives for Abstinence will be offered smoking cessation counseling and pharmacotherapy (standard care) and they will have the opportunity to earn small gift cards for biochemically-verified abstinence through 12 weeks post-quit. The amount of the gift cards will escalate each week from the quit date through 4 weeks post-quit with continuous abstinence. Participants who are non-abstinent at any visit may earn incentives for abstinence at the next visit, but the amount will reset to the starting level. Participants may additionally earn an additional gift card for abstinence at the 8 and 12 weeks post-quit visits.

Behavioral: Standard Care + Financial Incentives

Standard Care

ACTIVE COMPARATOR

Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.

Other: Standard Care

Interventions

Standard Care + Financial Incentives BEHAVIORAL

Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.

Standard Care + Financial Incentives

Standard Care OTHER

Tobacco cessation counseling plus pharmacotherapy.

Standard Care

Eligibility Criteria

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

You may qualify if:

• are currently uninsured or receiving Medicaid benefits
• earn a score ≥ 4 on the REALM indicating \> 6th grade English literacy level
• are willing to quit smoking 7 days from their first visit
• are ≥ 18 years of age
• have an expired CO level ≥ 8 ppm suggestive of current smoking
• are currently smoking ≥ 5 cigarettes per day
• are willing and able to attend 9 study visits.

You may not qualify if:

• are unwilling to quit smoking 7 days from their first visit
• have already quit smoking
• earn a score \<4 on the REALM indicating \< 7th grade literacy level
• produce an expired CO level \< 8 ppm
• are currently smoking \< 5 cigarettes per day
• are unwilling or unable to attend study visits
• are \< 18 years of age
• are not uninsured or receiving Medicaid benefits

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (3)

• Liang M, Koslovsky MD, Hebert ET, Kendzor DE, Businelle MS, Vannucci M. Bayesian continuous-time hidden Markov models with covariate selection for intensive longitudinal data with measurement error. Psychol Methods. 2023 Aug;28(4):880-894. doi: 10.1037/met0000433. Epub 2021 Dec 20.

  PMID: 34928674 RESULT

• Kendzor DE, Businelle MS, Frank-Pearce SG, Waring JJC, Chen S, Hebert ET, Swartz MD, Alexander AC, Sifat MS, Boozary LK, Wetter DW. Financial Incentives for Smoking Cessation Among Socioeconomically Disadvantaged Adults: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2418821. doi: 10.1001/jamanetworkopen.2024.18821.

  PMID: 38954415 RESULT

• Boozary LK, Chen M, Frank-Pearce SG, Hebert ET, Chen S, Alexander AC, Ogunsanya ME, Sifat MS, Oliver JA, Businelle MS, Kendzor DE. Discrimination experiences are associated with same-day and next-day smoking among adults with low socio-economic status trying to quit: A secondary analysis of data from a randomized clinical trial. Addiction. 2026 Apr 30. doi: 10.1111/add.70419. Online ahead of print.

  PMID: 42057652 RESULT

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Study enrollment occurred from 2017-2021. As a result, a total of 146 (45.6%) of participants received treatment and/or had scheduled study assessments following the onset of the COVID-19 pandemic (in March 2020). The pandemic may have affected smoking cessation outcomes and other study variables, including retention and study follow-up rates through a variety of influences (e.g., institutional restrictions on research, financial, stress/mental health).

Results Point of Contact

• Title: Dr. Darla Kendzor
• Organization: The University of Oklahoma Health Sciences Center

Darla-Kendzor@ouhsc.edu

(405) 271-8001

Study Officials

• Darla E. Kendzor, Ph.D.

  University of Oklahoma Health Campus

  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

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 14, 2016
• Study Start: January 30, 2017
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: May 13, 2026
• Results First Posted: April 20, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)