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Smoking, CigarettePhase 2NCT06296849

Dyadic Financial Incentive Treatments for Dual Smoker Couples

A Phase 2 study testing Financial Incentive Treatment (FIT) in people with Smoking, Cigarette, run by University of Oklahoma at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking, Cigarette
What is being tested?
Financial Incentive Treatment (FIT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
2 sitesUnited States
Study dates
18 Jan 2024to May 2028
Phase
Phase 2
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic relationship duration of at least six months.

Who cannot join

  • 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use.
  • Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michelle R vanDellen, PhD contact

762-499-4263

Michelle-vanDellen@ou.edu

United States2 sites, 1 recruiting
  • University of Georgia

    Athens, Georgia, 30602

    Completed
  • University of Oklahoma Health Campus

    Tulsa, Oklahoma, 74135

    Michelle vanDellen, PhD, mablab@ou.edu

    Kirsten Blum, MS, kirsten-blum@ou.edu

    Recruiting

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Dyadic Financial Incentive Treatments for Dual Smoker Couples: Evaluation of Efficacy, Mechanisms, and Cost Effectiveness (1R01CA276594-01A1)

Smokers partnered with other smokers (i.e., dual-smoker couples) represent ~2/3 of all smokers. Dual-smoker couples (DSCs) are less likely to try to quit smoking and more likely to relapse during a quit attempt, reducing overall smoking cessation rates and representing a high-risk clinical population. Despite their high prevalence and risk for persistent smoking, however, there are limited data on smoking cessation interventions among DSCs. Building on previous research that suggests a) financial incentive treatments (FITs) are effective at increasing quit rates and b) dyadic adaptations of FITs are feasible for implementation in DSCs, the proposed study will systematically two versions of FITs to enhance smoking cessation among DSCs. In addition to determining the efficacy of these dyadic FITs for smoking abstinence in DSCs, the investigators will consider the cost and cost effectiveness of each adaptation as well as mechanisms of change to inform future implementation research. The investigators will additionally consider secondary outcomes including abstinence during treatment and long-term abstinence maintenance after end of treatment.

The investigators will address these questions in a three-group randomized controlled trial (RCT). In all conditions, individuals who have smoking partners (i.e., targets) will receive usual care (combination fast and slow acting Nicotine Replacement Therapy + quitting resources). In two conditions, participants will receive incentives for abstinence at three time points (1, 3, and 6 months post-baseline). In the SFIT condition, only the target in a couple will be offered incentives; in the DFIT condition, both target and partner will be offered incentives. Primary efficacy outcome is % point-prevalence abstinence at 6 months post-baseline among targets. Secondary outcomes are point-prevalence abstinence at 1 and 3 months during the treatment and 6 months post-treatment (12-months post-baseline), as well as partner outcomes. The investigators will evaluate possible mechanisms of change including partner support and individual and partner motivation to quit as well as evaluate the cost and relative cost of each abstainer within and across condition. These data on the efficacy, mechanisms, and costs of FITs for DSCs will inform population level implementation and promote successful quitting in this treatment refractory population.

Read the detailed description

The proposed study investigates the efficacy of implementing Financial Incentivized Treatments (FITs) in dyads on smoking abstinence in DSCs. The core design is a three-group longitudinal design in which participants are randomized into one of three conditions (no-FIT control, SFIT (one couple member offered incentives) and DFIT (both couple members offered incentives and tracked across 12 months. During this time, participants will complete a baseline session, be offered quitting resources (e.g. psychoeducation, NRT), and complete four follow-ups (1, 3, 6 [primary efficacy timepoint], and 12 months scheduled post-baseline). In all conditions, all participants (both targets and partners) will receive combination fast- and slow-acting NRT (calibrated to their smoking heaviness and/or time to first cigarette) and access to quitting resources.

In all conditions, the target will be determined as the first person to make contact with the research team in response to study advertising. The investigators estimate 70% of targets will be female. The investigators will stratify to create approximately equal proportions of target sex by cell. Same sex couples will be independently stratified across conditions to attempt to balance proportionate representation (estimated prevalence of same sex couples = 8%). Because heaviness of smoking (<20 vs 20+ cigarettes/day) requires a different NRT regimen and heaviness of smoking is associated with different quit rates, the investigators will also stratify random assignment based on number of cigarettes per day. Collectively, these strategies will enhance the likelihood of equivalent composition by condition.

Targets will be randomly assigned to one of three conditions. Consistent with the R21 design, participants in the no-FIT control condition will not receive incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]). In the DFIT condition, both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition. However, because partners are involved in learning about the incentives, partner involvement is relatively high in both conditions. Partner involvement and understanding of the situation will be assessed as a potential mechanism of FIT efficacy. This design extends our pilot study to examine the efficacy of FITs for long-term abstinence and then then examines whether offering incentives to both members adds additional benefit beyond offering incentives to one member of the couple.

A total of 450 DSC targets (900 total smokers) will be recruited from across the United States. In all conditions, the target will be determined as the first person to contact the research team in response to study advertising. Couples will be defined as two people involved in a romantic relationship for at least 6 months who are married or cohabiting. Inclusion criteria are: 1) age of 18+; 2) smoking of 5+ cigarettes/day; 3) relationship status of married to or living with a daily smoker of 5+ cigarettes who is also above the age of 18; and 4) romantic Exclusion criteria are: 1) less than 8th grade capacity to read and write in English; 2) recent hospitalization (past 6 months) 3) psychosis risk; 4) regular (4+ days weekly) use of e-cigarettes; 5) Contra-indication for NRT (e.g., pregnancy, heart disease); 6) Marijuana use. Inclusion and exclusion criteria apply to both members of each couple; both members of each couple must be eligible for the target to enroll. Inclusion and exclusion criteria apply to both members of each couple. Study participation will last 1 year, including an initial Baseline session, three incentivized follow-ups (1 Mth, 3 Mth, 6 Mth follow-ups) and an unincentivized follow-up (12 Mth). Both members of each couple will be assessed at each time point, regardless of condition. Assessments will be completed by targets and partners via remote video conference at Baseline, 1 Mth, 3 Mth, 6 Mth, and 1 year. The investigators will measure smoking history, point-prevalence abstinence, heaviness of smoking, nicotine dependence, and possible motivational and dyadic mechanisms and moderators of anticipated effects.

Being tested
Financial Incentive Treatment (FIT)
Keywords
smoking cessation, dual-smoker couples, behavioral economics, financial incentives
Medical subject headings
Cigarette Smoking, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial Incentive Treatment (FIT)Behavioural

    In the present study, the investigators will provide financial incentives of $200 for biochemically verified abstinence at each of three time points (1 month, 3 month, and 6 month) following baseline. Additionally, the investigators will provide a bonus of $200 for participants who demonstrate abstinence at each of the time points. This incentive value is consistent with recent research using macro-level financial incentives and incorporates both short-term and long-term incentives to shape behavior.

Study groups in NCT06296849
Study groupRoleWhat they receive
No-FIT Treatment-as-Usual (TAU) ConditionNo interventionParticipants in the no-FIT control condition will not receive incentives.
Single-Target FIT (SFIT)ExperimentalOne couple member offered incentives. Targets in the SFIT condition will be offered financial incentives for biochemically verified abstinence ($200 at each of three follow-ups [1, 3, and 6 Month]).
Receives: Behavioral: Financial Incentive Treatment (FIT)
Dyadic-FIT condition (DFIT)ExperimentalBoth couple members offered incentives and tracked across 12 months. Both targets and partners will be offered financial incentives for abstinence. Thus, in this condition, the total financial incentives offered to the dyad are twice the amount as offered to participants in the SFIT condition.
Receives: Behavioral: Financial Incentive Treatment (FIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Point-Prevalence Abstinence at End of Treatment

    % of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired carbon monoxide (CO) <= 5 ppm

    Measured: 6 Month

Secondary outcomes (5)
  1. Point-Prevalence Abstinence After Treatment

    % of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm

    Measured: 1 year

  2. Point-Prevalence Abstinence at First Follow-up

    % of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm

    Measured: 1 month

  3. Point-Prevalence Abstinence at Second Follow-up

    % of targets (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm

    Measured: 3 month

  4. Partner Point-Prevalence Abstinence

    % of partners (intent to treat sample) who are abstinent (self-report no smoking past 7 days + expired CO <= 5 ppm at each follow-up

    Measured: 1 Month, 3 Month, 6 Month, 1 Year

  5. Smoking Heaviness

    All participants will report their average daily cigarette consumption at each time point.

    Measured: 1 Month, 3 Month, 6 Month, 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start18 Jan 2024
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06296849
Sponsor's protocol ID
17460
Status last verified
Apr 2026
First submitted
29 Feb 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be shared including key study variables (predictors and outcomes) through Open Science Framework (OSF).

Publications

  • vanDellen MR, Wright JWC, Zhao B, Cullinan C, Beach SRH, Shen Y, Haskins LB, Schiavone WM, MacKillop JM. Partner-Involved Financial Incentives for Smoking Cessation in Dual-Smoker Couples: A Randomized Pilot Trial. Nicotine Tob Res. 2024 Jan 22;26(2):229-236. doi: 10.1093/ntr/ntad183.

    PubMed 37742229

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Financial Incentive Treatment (FIT) in people with Smoking, Cigarette, run by University of Oklahoma at 2 sites 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

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 Michelle R vanDellen, PhD (762-499-4263, Michelle-vanDellen@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Point-Prevalence Abstinence at End of Treatment (time frame: 6 Month). 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 NCT06296849, 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 29 Apr 2026.

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