Smoking CessationNCT07685899
Contingency Management to Promote Smoking Cessation Study
A study testing Health Rewards in people with Smoking Cessation, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Health Rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoked in the past 30 days
- Smoke at least 1 cigarette per day when they smoke
- ≥ 18 years old
- Kansas resident
- Speak/read English
- Access to a mobile phone
Show all 12Show fewer
- Mobile phone receives text messages
- No varenicline contraindications (no acute renal impairment)
- Have no significant co-morbidity (i.e., life-threatening illness, communication barriers or altered mental status)
- Cognitively able to participate
- Physically able to participate
- Not pregnant/breastfeeding
Who cannot join
- Medically ineligible for varenicline
- Patient on smoking cessation medication within 2 weeks of admission date
- Patient already talked to quitline in the past 2 weeks.
- Patients participating in other quit smoking program or research study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66103
Erica Cruvinel, 913-526-0774, ecruvinel@kumc.edu
About this study
Official title: Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem, the investigators will recruit 40 patients for a pilot 2-arm effectiveness trial. Investigators will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.
Read the detailed description
Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.
The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.
- Conditions
- Smoking Cessation
- Being tested
- Health Rewards, Control
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health RewardsBehavioural
All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM).
ControlBehavioural
All participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline.
| Study group | Role | What they receive |
|---|---|---|
| CounsCM+MedCM | Experimental | Mobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM) Receives: Behavioral: Health Rewards |
| Control | Active comparator | 12 weeks of varenicline and referral to state quitline Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility outcomes
Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.
Measured: Week 3 to 12
Proportion of quitline calls completed
Completion of the five quitline calls according to Kansas quitline reports
Measured: Week 12
Proportion of varenicline pills taken
Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting
Measured: Week 12
Secondary outcomes (2)
Proportion of patients with biochemically verified smoking abstinence
Biochemically confirmed 7-day point prevalence abstinence using the anabasine criteria cutoff of ≤ 2 ng/ml
Measured: Week 12
Proportion of patients with self-reported smoking abstinence
Past 7 days self-reported smoking abstinence
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start6 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Oklahoma, University of Toronto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685899
- Sponsor's protocol ID
- DA055779-2
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contingency Management to Promote Smoking Cessation: A Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07685899
- Acronym / sponsor ID
- DA055779-2
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Oklahoma, University of Toronto
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adherence to medication and counseling are strong predictors of smoking cessation success. To provide these two components of care, healthcare providers typically provide people who smoke with prescriptions for cessation medications, and refer them to state-sponsored tobacco quitlines. However, most people who smoke that are referred to quitlines never actually enroll, and those who do enroll participate in very few sessions. Similarly, most people who smoke that receive prescriptions for cessation medications rarely fill or use them, even when they have no co-pay or pre-authorization requirements. To address this problem, the investigators will recruit 40 patients for a pilot 2-arm effectiveness trial. Investigators will recruit patients from the University of Kansas Medical Center. Participants will then be randomized either to control or Health Reward. All participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline (Control condition). In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). The use of medication will be tracked using an electronic pill dispenser (Wisepill). All participants will be contacted for follow up 3, 6 and 12 weeks after starting the treatment. Feasibility data will include recruitment and retention rates. Preliminary effectiveness outcomes will include treatment engagement and cessation rates.
Detailed description
Novel approaches are needed to engage people who smoke in treatment in a way that increases their odds of quitting. Contingency management (CM) interventions provide financial incentives to participants contingent on objective evidence of behavior change and are effective in enhancing medication adherence and treatment engagement for numerous health conditions, including tobacco dependence treatment. Critical gaps, however, remain in our knowledge regarding how best to deploy CM.
The goal of this study is to evaluate the acceptability and feasibility of combined CM for engaging patients in smoking cessation treatment. Participants (N=20) will receive "CounsCM" for engaging in five quitline calls and "MedCM" for utilizing varenicline over twelve weeks. CM payments will be automated and dispensed on a daily basis using a reloadable debit card. The investigators will use surveys and structured interviews to understand strengths, weaknesses, and areas for improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CounsCM+MedCM | Experimental | Behavioral: Health RewardsMobile Contingency management for counseling attendance (CounsCM) and medication intake (MedCM) |
| Control | Active comparator | Behavioral: Control12 weeks of varenicline and referral to state quitline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Smoked in the past 30 days
- Smoke at least 1 cigarette per day when they smoke
- ≥ 18 years old
- Kansas resident
- Speak/read English
Key exclusion criteria (4 listed)
- Medically ineligible for varenicline
- Patient on smoking cessation medication within 2 weeks of admission date
- Patient already talked to quitline in the past 2 weeks.
- Patients participating in other quit smoking program or research study
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 |
|---|---|---|
| Health RewardsAll participants will receive 12 weeks of varenicline and referrals to their state tobacco quitline. In Health rewards arm, participants will additionally receive CM for medication (MedCM) and for counseling (CounsCM). | Behavioural | CounsCM+MedCM |
| ControlAll participants in the control group will receive 12 weeks of varenicline and referrals to their state tobacco quitline. | Behavioural | Control |
Primary outcome
Feasibility outcomes
Time frame: Week 3 to 12
Feasibility endpoints include: (1) the proportion of eligible subjects who subsequently enroll; and (2) the proportion of enrolled subjects who complete the 3-week, 6-week, and 12-week assessments.
Proportion of quitline calls completed
Time frame: Week 12
Completion of the five quitline calls according to Kansas quitline reports
Proportion of varenicline pills taken
Time frame: Week 12
Varenicline intake over 12 weeks of treatment according to the smart pill dispenser counting
2 secondary outcomes
Proportion of patients with biochemically verified smoking abstinence
Time frame: Week 12
Proportion of patients with self-reported smoking abstinence
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Rewards in people with Smoking Cessation, run by University of Kansas Medical Center 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 12 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Cruvinel (913-945-6966, ecruvinel@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility outcomes (time frame: Week 3 to 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.