Financial Incentives for Smoking Cessation

Overseen By Kimberly S Cherewick

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Georgia

Must be taking: Nicotine replacement

Disqualifiers: Psychosis, E-cigarettes, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 months

900 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you will receive usual care, which includes Nicotine Replacement Therapy, so it's best to discuss with the trial team if you have concerns about your current medications.

What data supports the effectiveness of the treatment Financial Incentive Treatment (FIT) for smoking cessation?

Research shows that financial incentives can be effective in helping people quit smoking, especially when combined with other support like group training. Studies have found that offering financial rewards can increase the chances of quitting, even in challenging situations like pregnancy or among low-income individuals. ^{1 2 3 4 5}

Is the Financial Incentive Treatment for smoking cessation safe for humans?

The research articles provided do not contain specific safety data regarding the use of financial incentives for smoking cessation, focusing instead on effectiveness and perceptions. ^{1 2 3 6 7}

How is the Financial Incentive Treatment (FIT) for smoking cessation different from other treatments?

The Financial Incentive Treatment (FIT) is unique because it uses financial rewards to motivate people to quit smoking, which is different from traditional methods like nicotine replacement therapies or counseling. This approach can be combined with other interventions, such as group training, to potentially increase its effectiveness. ^{1 2 4 7 8}

What is the purpose of this trial?

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.

Research Team

Michelle R vanDellen, PhD

Principal Investigator

University of Georgia

Eligibility Criteria

This trial is for couples where both partners smoke cigarettes. They must be willing to try quitting together and participate in a study that involves financial incentives as motivation. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and commit to the study's schedule.

Inclusion Criteria

Romantic relationship duration of at least six months

Smoking of 5+ cigarettes/day

I am married to or live with someone over 18 who smokes more than 5 cigarettes daily.

Exclusion Criteria

Marijuana use

Less than 8th grade capacity to read and write in English

Psychosis risk

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants complete a baseline session and are offered quitting resources

1 session

1 visit (remote video conference)

Treatment

Participants receive financial incentives for abstinence at 1, 3, and 6 months post-baseline

6 months

3 visits (remote video conference)

Follow-up

Participants are monitored for long-term abstinence and smoking behavior

6 months

1 visit (remote video conference)

Treatment Details

Interventions

• Financial Incentive Treatment (FIT)

Trial Overview The trial tests two versions of Financial Incentive Treatments (FITs) designed to help dual-smoker couples quit smoking. Participants will receive usual care plus potential cash rewards for abstaining from smoking at set intervals. One group gets incentives just for one partner, while the other group has both partners receiving incentives.

Participant Groups

Group I: Single-Target FIT (SFIT) Experimental Treatment 1 Intervention

One 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 \[1, 3, and 6 Month\]).

Group II: Dyadic-FIT condition (DFIT) Experimental Treatment 1 Intervention

Both 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.

Group III: No-FIT Treatment-as-Usual (TAU) Condition Active Control 1 Intervention

Participants in the no-FIT control condition will not receive incentives.

Financial Incentive Treatment (FIT) is already approved in United States, European Union for the following indications:

Approved in United States as Financial Incentive Treatment for:

• Smoking cessation

Approved in European Union as Financial Incentive Treatment for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Georgia

Lead Sponsor

Trials

109

Recruited

43,500+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

Findings from Research

A study involving 3,816 Medicaid beneficiaries found that modest financial incentives significantly improved smoking cessation outcomes, including quit attempts and abstinence rates, compared to usual care.

Participants receiving nicotine patches along with financial incentives were more likely to achieve both short-term (7-day and 30-day) and long-term (6-month) abstinence, demonstrating the effectiveness of integrating financial incentives into smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentives and Patches for Medicaid Smokers: An RCT. Anderson, CM., Cummins, SE., Kohatsu, ND., et al.[2019]

In a study involving 239 pregnant smokers in England, financial incentives for quitting smoking led to a 20% cessation rate at delivery and a 10% cessation rate at 6 months postpartum, indicating prolonged effectiveness similar to previous US trials.

The study found minimal evidence of 'gaming' or false reporting among participants, with only 4% of enrolled women attempting to misreport their smoking status to gain incentives, suggesting that financial incentive schemes can be implemented with integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Financial incentives for smoking cessation in pregnancy: a single-arm intervention study assessing cessation and gaming. Ierfino, D., Mantzari, E., Hirst, J., et al.[2022]

Financial incentives for healthcare professionals can enhance the recording of patients' smoking status and increase the provision of smoking cessation advice, as shown in a systematic review of 18 studies.

However, the evidence is mixed regarding whether these financial incentives actually lead to significant reductions in smoking rates or improved long-term abstinence, indicating that more research is needed in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of providing financial incentives to healthcare professionals for smoking cessation activities: systematic review. Hamilton, FL., Greaves, F., Majeed, A., et al.[2018]

A study involving 604 smokers from 61 companies in the Netherlands found that financial incentives combined with a smoking cessation group training program significantly increased the 12-month abstinence rates, with 41% of participants in the incentive group remaining smoke-free compared to 26% in the control group.

The adjusted odds ratio of 1.93 indicates that participants receiving financial incentives were nearly twice as likely to quit smoking successfully, suggesting that such incentives could be an effective strategy for workplace smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a workplace-based group training programme combined with financial incentives on smoking cessation: a cluster-randomised controlled trial. van den Brand, FA., Nagelhout, GE., Winkens, B., et al.[2019]

The FIESTA II study is a randomized controlled trial designed to evaluate the effectiveness of financial incentives in promoting smoking cessation among hospitalized smokers, with participants recruited from underserved communities in New York City and Los Angeles.

Participants will be divided into three groups: one receiving goal-directed financial incentives, another receiving outcome-based incentives, and a control group receiving standard care, with the potential to earn significant rewards for completing follow-up interviews and achieving smoking cessation milestones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Goal-directed versus outcome-based financial incentives for smoking cessation among low-income, hospitalised patients: rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) randomised controlled trial. Wali, S., Gaitonde, A., Sherman, S., et al.[2023]

In a study involving 179 smokers, modest financial incentives significantly increased enrollment (43.3% vs. 20.2%) and completion (25.8% vs. 12.2%) of a smoking cessation program, indicating that financial rewards can effectively motivate participation in such programs.

The incentive group achieved a higher short-term quit rate at 75 days (16.3% vs. 4.6%), but this difference was not maintained at 6 months, suggesting that while incentives can boost initial success, additional strategies may be needed for long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of financial incentives for smoking cessation. Volpp, KG., Gurmankin Levy, A., Asch, DA., et al.[2022]

Only 38.4% of smokers supported financial incentives for smoking cessation, with support being higher among heavy smokers and those who recently attempted to quit, indicating a need for better education on the effectiveness of such schemes.

Concerns about personal responsibility, potential abuse of the system, and fairness were major reasons for opposition to financial incentives, suggesting that addressing these issues through media advocacy could increase acceptance and implementation of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Financial Incentives for Smoking Cessation: A Survey of Smokers in a Country With an Endgame Goal. Robertson, L., Gendall, P., Hoek, J., et al.[2019]

A review of 26 studies on financial incentive programs for smoking cessation found that higher incentive amounts did not correlate with higher quit rates, suggesting that simply increasing financial rewards may not be effective in promoting smoking cessation.

The study highlighted the need for further research to determine optimal financial incentive amounts and their cost-effectiveness, as current evidence is insufficient to draw definitive conclusions due to variations in study designs and populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher incentive amounts do not appear to be associated with greater quit rates in financial incentive programmes for smoking cessation. Breen, RJ., Ferguson, SG., Palmer, MA.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Incentives and Patches for Medicaid Smokers: An RCT. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Financial incentives for smoking cessation in pregnancy: a single-arm intervention study assessing cessation and gaming. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of providing financial incentives to healthcare professionals for smoking cessation activities: systematic review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Effect of a workplace-based group training programme combined with financial incentives on smoking cessation: a cluster-randomised controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Goal-directed versus outcome-based financial incentives for smoking cessation among low-income, hospitalised patients: rationale and design of the Financial Incentives for Smoking Treatment II (FIESTA II) randomised controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of financial incentives for smoking cessation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Perceptions of Financial Incentives for Smoking Cessation: A Survey of Smokers in a Country With an Endgame Goal. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Higher incentive amounts do not appear to be associated with greater quit rates in financial incentive programmes for smoking cessation. [2021]