Contingency Management for Tobacco Use Disorder

(CM_TUD_Cancer Trial)

Overseen By Madeline Martinez Rivas, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic disorders, Bipolar, Neurocognitive, 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

95 Participants Needed

Trial Summary

What is the purpose of this trial?

Tobacco use among US Veterans poses significant health problems and challenges to their overall well-being. The aim of this project is to evaluate the effectiveness of a program called Contingency Management (CM) in helping Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a behavioral treatment that uses rewards to encourage smoking cessation when verified through biological testing. In the first year, the researchers will develop a mobile CM protocol based on feedback from Veterans and healthcare staff through focus groups. In the second year, they will conduct a pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans over a five-week period. The success of the pilot study will determine whether to proceed with a larger randomized controlled trial (RCT) in years three to six, comparing the efficacy of mobile CM with standard treatment. The project will take place at SFVA.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Contingency Management for Tobacco Use Disorder?

Research shows that using rewards or incentives, like in Contingency Management, can help people quit smoking. Studies found that offering prizes or financial incentives for not smoking can increase the chances of quitting, especially when the rewards are given immediately and increase over time. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management, which involves using rewards to encourage behavior change, has been studied in various settings and appears to be safe for humans. It has been used effectively in controlled environments for smoking cessation and other substance use treatments without significant safety concerns. ^{1 2 3 6 7}

How does the Contingency Management treatment for tobacco use disorder differ from other treatments?

Contingency Management is unique because it uses tangible rewards, like prizes, to encourage smoking cessation by providing incentives for demonstrating smoking abstinence, which is different from traditional methods that may not involve direct rewards. ^{1 2 8 9 10}

Research Team

Ellen Herbst, MD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for US Veterans who are either undergoing lung cancer screening or receiving cancer care at VA clinics and want to quit smoking. They must be willing to participate in focus groups, use a mobile program, and undergo biological testing to verify smoking cessation.

Inclusion Criteria

Have participated in the care of at least 5 VA cancer or LCS patients in the past 6 months

Active cigarette smoking within the past 24 months

Veteran eligible for VA healthcare

Exclusion Criteria

Veterans: Assessed by Co-PIs' medical record review: Current severe, untreated mental illness (i.e., psychosis, bipolar disorder, and/or substance use disorder (SUD)) and/or Current (past 30 days) active suicidal/homicidal ideation or severe behavioral instability that would prevent participation

Untreated, current, active problem gambling, assessed by medical record diagnosis and/ or Problem Gambling Severity Index (PGSI) score 8

My cancer has spread, or I am receiving end-of-life care.

Timeline

Focus Group Development

Development of a mobile CM protocol using qualitative feedback from Veterans and healthcare staff through focus groups.

1 year

Pilot Study

Pilot study to test the feasibility of the mobile CM program along with counseling and medication for 20 Veterans.

5 weeks

Weekly visits (in-person or virtual)

Randomized Controlled Trial (RCT)

RCT to assess the efficacy of mobile CM compared with treatment as usual among Veterans diagnosed with cancer or in lung cancer screening.

3 years

Visits at Weeks 0, 5, 12, 24

Follow-up

Participants are monitored for safety and effectiveness after treatment.

24 weeks

Follow-up visits at Weeks 5, 12, 24

Treatment Details

Interventions

• Contingency Management

Trial Overview The study tests Contingency Management (CM), which rewards Veterans for quitting smoking, verified by tests. It includes developing a mobile CM protocol with Veteran/staff input, then piloting it alongside counseling and medication over five weeks to assess feasibility.

Participant Groups

Group I: Focus Group Experimental Treatment 1 Intervention

The investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff.

Group II: Contingency Management Experimental Treatment 2 Interventions

Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.

Group III: TUD Treatment as Usual Active Control 2 Interventions

Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline).

Contingency Management is already approved in United States, European Union for the following indications:

Approved in United States as Contingency Management for:

• Substance Use Disorders
• Stimulant Use Disorder
• Methamphetamine Use Disorder

Approved in European Union as Contingency Management for:

• Substance Use Disorders
• Addiction Treatment

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Findings from Research

In a study involving 81 nicotine-dependent smokers, the addition of prize-based contingency management (CM) to standard care significantly reduced smoking during treatment compared to standard care alone.

However, these reductions in smoking did not persist after the treatment ended, indicating that while prize CM can be effective in the short term, it may not lead to long-term cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prize contingency management for smoking cessation: a randomized trial. Ledgerwood, DM., Arfken, CL., Petry, NM., et al.[2022]

Incentive and contingency management strategies have shown effectiveness in modifying smoking behavior, particularly in controlled settings, suggesting they can be beneficial for smoking cessation efforts.

Quit-and-win programs, which use incentives to encourage quitting, attract many participants and have produced modest quit rates, although the quality of evaluations varies and more rigorous studies are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. Donatelle, R., Hudson, D., Dobie, S., et al.[2006]

A survey of 214 substance use treatment providers revealed that while many clinics are using reward programs, they often do not follow effective practices recommended by research, such as providing higher reward amounts or immediate reinforcement.

Providers with more extensive training in contingency management (CM) were more likely to implement effective strategies, suggesting that better training could improve the quality of reward-based interventions in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining implementation of contingency management in real-world settings. Rash, CJ., Alessi, SM., Zajac, K.[2021]

In a study involving 75 socioeconomically disadvantaged adults, those who placed greater importance on earning financial incentives for smoking cessation were significantly more likely to achieve continuous abstinence during the four-week intervention (OR = 3.95) and up to 12 weeks post-quit day (OR = 4.71).

The results indicate that an individual's perception of the importance of financial incentives can predict their success in quitting smoking, suggesting that tailoring incentive programs to enhance perceived value may improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Greater perceived importance of earning abstinence-contingent incentives is associated with smoking cessation among socioeconomically disadvantaged adults. Alexander, AC., Hébert, ET., Businelle, MS., et al.[2022]

A contingency management procedure that rewards participants with accumulating money for abstaining from smoking led to a significantly higher likelihood of achieving a 48-hour period of abstinence compared to a procedure that deducted money for smoking.

Participants who earned money for continued abstinence were also less likely to miss appointments, indicating better engagement and adherence to the treatment program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relative contribution of economic valence to contingency management efficacy: a pilot study. Roll, JM., Howard, JT.[2021]

In a pilot study involving 84 low-income participants, a behavioral activation (BA) intervention combined with contingency management (CM) led to a significant reduction in cigarette smoking over time (p < .001).

The study also found that as participants continued to use BA skills, they experienced greater environmental rewards, suggesting that this approach may effectively support smoking cessation in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot trial of behavioural activation with a contingency management component: Preliminary examination of changes in smoking and alternative rewards among low-income individuals. Collado, A., Felton, JW., Bounoua, N., et al.[2023]

Internet-based deposit contracts for smoking cessation were effective in increasing the number of breath samples meeting the carbon monoxide criterion, with 47% success in Experiment 1 and 41.5% in Experiment 2, compared to virtually no success during baseline measurements.

Participants found the deposit contract interventions acceptable and feasible, indicating a positive reception that could support further research into their long-term effectiveness for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. Jarvis, BP., Dallery, J.[2018]

In a study involving 142 outpatients with cocaine or heroin dependence, both voucher and prize-based contingency management (CM) interventions led to longer treatment retention and greater durations of confirmed abstinence compared to standard treatment.

While there were no significant differences in abstinence rates at 6- and 9-month follow-ups, the duration of abstinence achieved during treatment was the strongest predictor of continued abstinence after treatment ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. Petry, NM., Alessi, SM., Marx, J., et al.[2016]

Contingency management (CM) is an effective psychosocial treatment for substance use disorders that uses tangible rewards to reinforce drug-negative behaviors, showing strong efficacy based on behavioral analysis principles.

CM not only provides external rewards but may also enhance a patient's intrinsic motivation to change their substance use behavior, suggesting broader applications for this intervention beyond substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. Walter, KN., Petry, NM.[2016]

Contingency management procedures have been shown to effectively treat substance use disorders by providing rewards, like vouchers, for drug abstinence, particularly in psychosocial and methadone maintenance settings.

Recent adaptations of these procedures include using lower-cost reinforcers and expanding their application to improve treatment attendance, adherence to goals, and medication compliance, highlighting the versatility of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for treatment of substance abuse. Stitzer, M., Petry, N.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Prize contingency management for smoking cessation: a randomized trial. [2022]

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

Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. [2006]

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

Examining implementation of contingency management in real-world settings. [2021]

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

Greater perceived importance of earning abstinence-contingent incentives is associated with smoking cessation among socioeconomically disadvantaged adults. [2022]

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

The relative contribution of economic valence to contingency management efficacy: a pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A pilot trial of behavioural activation with a contingency management component: Preliminary examination of changes in smoking and alternative rewards among low-income individuals. [2023]

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

Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. [2018]

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

Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]

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

Contingency management for treatment of substance abuse. [2019]