Cigarette SmokingPhase 2CLIMBNCT05095779
Incentives for Oklahoma Tobacco Helpline Engagement in Persistent Poverty Counties
A Phase 2 study testing Coaching calls, Nicotine replacement therapy and Financial Incentives in people with Cigarette Smoking and Nicotine Dependence, run by University of Oklahoma at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Nicotine Dependence
- What is being tested?
- Coaching calls, Nicotine replacement therapy and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 11 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
TSET Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline in Counties Experiencing Persistent Poverty
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.
Read the detailed description
The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH (coaching calls + nicotine replacement therapy) or OTH plus escalating financial incentives (OTH+FI) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completions, follow-up assessment completion, smoking cessation, and incentive costs. Potential effectiveness will be evaluated based on comparisons of counseling call completions over the first 8 weeks post-enrollment and rates of self-reported smoking abstinence through 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+FI relative to OTH alone.
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Being tested
- Coaching calls, Nicotine replacement therapy, Financial Incentives
- Keywords
- Persistent Poverty, Smoking Cessation, Financial Incentives, Contingency Management, Tobacco Helpline, Tobacco Quitline, Socioeconomic Status
- Medical subject headings
- Cigarette Smoking, Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching callsBehavioural
OTH coaching calls
Nicotine replacement therapyDrug
8 weeks of nicotine replacement therapy
Financial IncentivesBehavioural
Escalating financial incentives for completing up to 5 coaching calls
| Study group | Role | What they receive |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Active comparator | Participants randomized to OTH will be offered coaching calls and nicotine replacement therapy. Receives: Behavioral: Coaching calls; Drug: 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. Receives: Behavioral: Coaching calls; Drug: Nicotine replacement therapy; Behavioral: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Abstinence
Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
Measured: 12 weeks post-enrollment
Secondary outcomes (6)
7-Day Point Prevalence Abstinence
Self-reported 7-day point prevalence abstinence at 8 weeks post-enrollment (missing considered smoking)
Measured: 8 weeks post-enrollment
Coaching Calls Completed (Total Number)
The total number of coaching calls completed.
Measured: First 8 weeks post-enrollment
Completed >=3 Coaching Calls
The proportion of participants who completed at least 3 coaching calls
Measured: First 8 weeks post-enrollment
Retention
The number of participants who completed the follow-up assessment.
Measured: 8 weeks post-enrollment
Retention
The number of participants who completed the follow-up assessment.
Measured: 12 weeks post-enrollment
Incentives Earned
The mean amount of call-contingent incentives earned among participants assigned to the OTH+FI group.
Measured: First 8 weeks post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start9 Mar 2022
- Primary completion11 Aug 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Tobacco Settlement Endowment Trust (TSET), National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Darla E. Kendzor, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095779
- Sponsor's protocol ID
- 13859
- Other IDs
- P30CA225520, K01MD015295, R25MD011564
- Acronym
- CLIMB
- Status last verified
- Dec 2024
- First submitted
- 14 Oct 2021
- Last updated
- 30 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39477130
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline in Counties Experiencing Persistent Poverty
- ClinicalTrials.gov ID
- NCT05095779
- Acronym / sponsor ID
- CLIMB / 13859
- Conditions
- Cigarette Smoking, Nicotine Dependence
- Keywords
- Persistent Poverty, Smoking Cessation, Financial Incentives, Contingency Management, Tobacco Helpline, Tobacco Quitline, Socioeconomic Status
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Tobacco Settlement Endowment Trust (TSET), National Cancer Institute (NCI), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 27 Oct 2021 (actual)
- Results
- Posted 16 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed randomized controlled trial will enroll adults who are seeking smoking cessation treatment through the OTH and who reside in any of the 16 PPCs in Oklahoma. Participants will be randomly assigned to OTH (coaching calls + nicotine replacement therapy) or OTH plus escalating financial incentives (OTH+FI) for completing up to 5 counseling calls over 8 weeks. Feasibility outcomes for the incentives-based intervention will focus on counseling call completions, follow-up assessment completion, smoking cessation, and incentive costs. Potential effectiveness will be evaluated based on comparisons of counseling call completions over the first 8 weeks post-enrollment and rates of self-reported smoking abstinence through 12 weeks post-enrollment (4 weeks after incentives have ended) in OTH+FI relative to OTH alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oklahoma Tobacco Helpline (OTH) | Active comparator | Behavioral: Coaching calls, Drug: Nicotine replacement therapyParticipants randomized to OTH will be offered coaching calls and nicotine replacement therapy. |
| OTH + Financial Incentives (OTH+FI) | Experimental | Behavioral: Coaching calls, Drug: Nicotine replacement therapy, Behavioral: Financial IncentivesParticipants will receive standard OTH care (coaching calls + nicotine replacement therapy) and escalating financial incentives for completing up to 5 coaching calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaching callsOTH coaching calls | Behavioural | OTH + Financial Incentives (OTH+FI), Oklahoma Tobacco Helpline (OTH) |
| Nicotine replacement therapy8 weeks of nicotine replacement therapy | Drug | OTH + Financial Incentives (OTH+FI), Oklahoma Tobacco Helpline (OTH) |
| Financial IncentivesEscalating financial incentives for completing up to 5 coaching calls | Behavioural | OTH + Financial Incentives (OTH+FI) |
Primary outcome
7-Day Point Prevalence Abstinence
Time frame: 12 weeks post-enrollment
Self-reported smoking abstinence 7-day point prevalence at 12 weeks post-enrollment (missing considered smoking).
6 secondary outcomes
7-Day Point Prevalence Abstinence
Time frame: 8 weeks post-enrollment
Coaching Calls Completed (Total Number)
Time frame: First 8 weeks post-enrollment
Completed >=3 Coaching Calls
Time frame: First 8 weeks post-enrollment
Retention
Time frame: 8 weeks post-enrollment
Retention
Time frame: 12 weeks post-enrollment
Incentives Earned
Time frame: First 8 weeks post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39477130Kendzor 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darla E. Kendzor, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Coaching calls, Nicotine replacement therapy and Financial Incentives in people with Cigarette Smoking and Nicotine Dependence, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalence Abstinence (time frame: 12 weeks post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05095779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.