NCT05095779

Brief Summary

The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation counseling and self-reported abstinence at follow-up among Oklahoma Tobacco Helpline (OTH) callers living in persistent poverty counties (PPCs). The study will enroll at least 160 adults who reside in any of the 16 persistent poverty counties in Oklahoma, who are seeking smoking cessation treatment through the OTH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 16, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

October 14, 2021

Results QC Date

June 20, 2024

Last Update Submit

December 12, 2024

Conditions

Keywords

Persistent PovertySmoking CessationFinancial IncentivesContingency ManagementTobacco HelplineTobacco QuitlineSocioeconomic Status

Outcome Measures

Primary Outcomes (1)

  • 7-Day Point Prevalence Abstinence

    Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).

    12 weeks post-enrollment

Secondary Outcomes (6)

  • 7-Day Point Prevalence Abstinence

    8 weeks post-enrollment

  • Coaching Calls Completed (Total Number)

    First 8 weeks post-enrollment

  • Completed >=3 Coaching Calls

    First 8 weeks post-enrollment

  • Retention

    8 weeks post-enrollment

  • Retention

    12 weeks post-enrollment

  • +1 more secondary outcomes

Study Arms (2)

Oklahoma Tobacco Helpline (OTH)

ACTIVE COMPARATOR

Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy.

Behavioral: Coaching callsDrug: Nicotine replacement therapy

OTH + Financial Incentives (OTH+FI)

EXPERIMENTAL

Participants will receive standard OTH care (coaching calls + nicotine replacement therapy) and escalating financial incentives for completing up to 5 coaching calls.

Behavioral: Coaching callsDrug: Nicotine replacement therapyBehavioral: Financial Incentives

Interventions

Coaching callsBEHAVIORAL

OTH coaching calls

OTH + Financial Incentives (OTH+FI)Oklahoma Tobacco Helpline (OTH)

8 weeks of nicotine replacement therapy

OTH + Financial Incentives (OTH+FI)Oklahoma Tobacco Helpline (OTH)

Escalating financial incentives for completing up to 5 coaching calls

OTH + Financial Incentives (OTH+FI)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Contact the OTH seeking smoking cessation treatment
  • Reside in any of the 16 PPCs in Oklahoma (Adair, Caddo, Cherokee, Choctaw, Greer, Harmon, Haskell, Hughes, Johnston, McCurtain, Okfuskee, Payne, Pushmataha, Seminole, Sequoyah, Tillman)
  • Report smoking ≥ 5 cigarettes per day
  • Are ≥ 18 years of age
  • Are able to provide a copy/photo of their ID/driver's license or other documentation of identity and residence
  • Be able to read, speak, and understand English
  • Have no contradictions for NRT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TSET Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Kendzor DE, Davie M, Chen M, Hart J, Frank-Pearce SG, Doescher MP, Alexander AC, Businelle MS, Ogunsanya ME, Sifat MS, Boozary LK. Incentivizing Tobacco Helpline Engagement in Persistent Poverty Counties: A Randomized Trial. Am J Prev Med. 2025 Feb;68(2):336-347. doi: 10.1016/j.amepre.2024.10.014. Epub 2024 Oct 29.

MeSH Terms

Conditions

Cigarette SmokingTobacco Use DisorderSmoking Cessation

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco SmokingSmokingBehaviorTobacco UseSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Dr. Darla E. Kendzor
Organization
The University of Oklahoma Health Sciences

Study Officials

  • Darla E. Kendzor, PhD

    University of Oklahoma

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

October 27, 2021

Study Start

March 9, 2022

Primary Completion

August 11, 2023

Study Completion

August 11, 2023

Last Updated

December 30, 2024

Results First Posted

July 16, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

De-identified data will be made available to investigators upon request, after publication of the primary study findings, and with a data-sharing agreement that specifies the investigator(s) will 1) use the data only for research purposes and not to identify any individual participant, 2) store the data on a secure device (e.g., encrypted, password-protected), and 3) destroy or return the data after completion of the analyses.

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