Mobile Contingency Management for Smoking Cessation

NCT04881630 | Active Not Recruiting DMC

• 2 other identifiers: 12881R01CA251451
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed project is to evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely benefit from financial incentives for smoking cessation. The investigators have previously combined technologies including 1) portable carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm participant identity during breath sample submissions, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported abstinence. This automated CM approach will be evaluated in a randomized controlled trial that includes 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to either telephone counseling and nicotine replacement therapy (standard care \[SC\]) or SC plus a mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 26 weeks after a scheduled quit attempt. Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit will be the primary outcome variable. Cost-effectiveness will be evaluated to inform policy-related decisions. Potential mobile CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future versions of the intervention.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Financial Incentives; Socioeconomic Status; Contingency Management; Mobile Health

Outcome Measures

Primary Outcomes (1)

• Carbon monoxide-verified smoking abstinence

  The primary outcome measure is carbon monoxide-verified 7-day point prevalence abstinence at 26 weeks post-quit.

  26 weeks post-quit-date

Secondary Outcomes (5)

• Cost-effectiveness

  26 weeks post-quit-date

• Carbon monoxide-verified smoking abstinence

  12 week post-quit-date

• Carbon monoxide-verified smoking abstinence

  8 weeks post-quit-date

• Carbon monoxide-verified smoking abstinence

  4 weeks post-quit-date

• Carbon monoxide-verified smoking abstinence

  26 weeks post-quit-date

Study Arms (2)

Standard Care (SC)

ACTIVE COMPARATOR

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

Other: Standard Care (SC)

Contingency Management (CM)

EXPERIMENTAL

CM participants will receive standard care in addition to small financial incentives for biochemically-verified abstinence.

Behavioral: Automated Mobile Contingency Management (CM); Other: Standard Care (SC)

Interventions

Automated Mobile Contingency Management (CM) BEHAVIORAL

Financial incentives contingent upon smoking abstinence

Contingency Management (CM)

Standard Care (SC) OTHER

Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)

Contingency Management (CM); Standard Care (SC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• report an annual household income of \<200% of the federal poverty threshold (i.e., low-income)
• earn a score ≥4 on the REALM indicating \>6th grade English literacy level (i.e., a 7th grade reading level is necessary to complete assessments)
• are willing to quit smoking 7-14 days after enrollment
• are ≥ 18 years of age
• currently smoke ≥ 5 cigarettes per day
• have a CO level of \>6 ppm
• are willing to abstain from smoking cannabis and other combustible tobacco products (they raise CO levels and mask cigarette abstinence)
• have no contraindications for NRT
• Provide a copy/photo of driver's license or other documentation as proof of identity and U.S. residence

Sponsors & Collaborators

• University of Oklahoma: lead
• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: collaborator
• University of Florida: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• Kendzor DE, Businelle MS, Vidrine DJ, Frank-Pearce SG, Shih YT, Dallery J, Alexander AC, Boozary LK, Waring JJC, Ehlke SJ. Mobile contingency management for smoking cessation among socioeconomically disadvantaged adults: Protocol for a randomized trial. Contemp Clin Trials. 2022 Mar;114:106701. doi: 10.1016/j.cct.2022.106701. Epub 2022 Jan 31.

  PMID: 35114409 BACKGROUND

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

Study Officials

• Darla E. Kendzor, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

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: March 29, 2021
• First Posted: May 11, 2021
• Study Start: November 8, 2022
• Primary Completion: January 31, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be made available to investigators upon request after publication of the primary study findings.
• Access Criteria: Data sharing agreement

Locations

US (1)