Contingency Management for Tobacco Use Disorder

(CM_Surgery Trial)

Overseen By Ellen Herbst, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

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: Unknown

Duration: 5 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help military Veterans quit smoking before and after major surgeries using a new mobile program that rewards them for staying smoke-free. This approach, known as Contingency Management (also called Motivational Incentives or the Prize Method), encourages positive behavior change. Smoking can lead to complications after surgery, so finding effective ways to help Veterans quit is crucial. Participants will either use this new program or receive regular care to determine which method works better. Veterans who smoke regularly and are scheduled for major elective surgery might be a good fit for this study. As an unphased study, this trial offers Veterans a unique opportunity to explore innovative methods to quit smoking and improve surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation for Veterans undergoing surgery.

What prior data suggests that this contingency management protocol is safe for Veterans undergoing major elective surgery?

Research shows that contingency management (CM) safely helps people quit smoking. Studies have found that CM uses rewards to motivate smoking cessation and has successfully reduced smoking during treatment. People generally find this method manageable because it involves tangible rewards, like prizes, to support quitting.

No reports of harmful side effects have emerged from using CM to quit smoking, suggesting it is a safe option for those trying to quit, including individuals preparing for surgery. Overall, CM appears to be a promising and safe method to aid smoking cessation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Contingency Management (CM) for Tobacco Use Disorder because it offers a fresh approach compared to standard treatments like nicotine replacement therapy or medications such as varenicline and bupropion. Unlike these traditional methods, CM focuses on providing motivational incentives to encourage quitting, which can be particularly effective for some individuals. This method combines behavioral therapy with tangible rewards, potentially increasing motivation and adherence to quitting plans. Additionally, integrating expert feedback and veteran-specific needs into the CM protocol makes it a tailored approach, promising better engagement and outcomes.

What evidence suggests that this contingency management protocol is effective for smoking cessation in Veterans undergoing major elective surgery?

Research shows that using rewards to encourage people to quit smoking, known as contingency management (CM), can be effective. In this trial, participants in the CM group will follow a VA CM Protocol and receive financial incentives to help quit smoking. Studies have found that offering financial incentives helps people stop smoking. For instance, one study discovered that individuals who received rewards for not smoking were more successful at quitting than those who did not. Another review confirmed that programs offering incentives effectively reduce smoking rates. Although this method has not been used before major surgery, evidence suggests it could be a promising way to help Veterans quit smoking during this important time. ^{2 3 4 6 7}

Who Is on the Research Team?

Ellen Herbst, MD

Principal Investigator

San Francisco VA Health Care System

Are You a Good Fit for This Trial?

This trial is for military Veterans who smoke and are scheduled for major elective surgery. They should be motivated to quit smoking, as the study aims to reduce postoperative complications linked to tobacco use. Specific eligibility details aren't provided, but typically participants must meet certain health criteria.

Inclusion Criteria

Current (past 30 days) cigarette smoking a minimum of 2 cigarettes per day (average), assessed by Timeline Followback (TLFB)

I am willing to try methods to stop smoking.

Veteran enrolled in healthcare at SFVAHCS

Exclusion Criteria

I cannot commit to the trial's schedule.

Evaluated by investigative team medical record review and clinical assessment: Psychotic disorders, bipolar disorder, neurocognitive disorder, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on M.I.N.I. Neuropsychiatric Inventory (M.I.N.I.) and/or medical record review

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 5-week mobile contingency management (CM) smoking cessation intervention or treatment as usual (TAU) with pharmacotherapy

5 weeks

Weekly virtual check-ins

Follow-up

Participants are monitored for smoking cessation outcomes and feasibility measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency Management

Trial Overview The study tests a mobile contingency management (CM) program that rewards Veterans when they stop smoking, verified through bioverification methods. It's designed specifically for those about to undergo or have just had surgery.

How Is the Trial Designed?

Group I: Contingency Management (CM) Experimental Treatment 1 Intervention

A VA CM Protocol will be established after gathering feedbacks from focus groups with Veterans and advice from the experts in 1) surgical care, 2) CM, and 3) VA policy. The CM intervention group will follow the established VA CM Protocol to deliver treatment over 5 weeks. The participants in the CM group will also be offered a 5-week supply of medication for Tobacco Use Disorder (TUD).

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Participants assigned to TAU will receive usual care at San Francisco VA Health Care System (referral to Tobacco Cessation Clinic and the VA Telequit Quitline) over the 5 weeks. They will also be offered a 5-week supply of medication for Tobacco Use Disorder (TUD).

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?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Published Research Related to This Trial

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 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]

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]

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]

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]

In a study involving 34 individuals with Cocaine Use Disorder, larger fixed incentives for providing negative urine samples led to faster and more effective abstinence compared to smaller incentives.

The type of incentive structure (escalating and resetting vs. fixed) did not significantly impact the overall effectiveness, suggesting that the magnitude of the incentive is more crucial for promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. Regnier, SD., Strickland, JC., Stoops, WW.[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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5020416/

Prize Contingency Management for Smoking Cessation Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention, but the benefits did not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3411852/

The Use of Financial Incentives in Promoting Smoking ... We review research on the systematic use of financial incentives to promote abstinence from smoking. Incentive-based interventions, also known as contingency ...

3. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004307.pub7/references

Incentives for smoking cessation - Notley, C - 2025 A randomized trial of contingency management for smoking cessation in the ... Reward-based incentives for smoking cessation: how a carrot became a stick.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1697260015000484

Voucher-based contingency management and in-treatment ... The present study assessed the effect of Contingency Management (CM) combined with Cognitive-Behavioral Treatment (CBT) on certain in-treatment behaviors.

5. academic.oup.com academic.oup.com/ntr/article/27/8/1319/8023214

Financial Incentives for Substance Abstinence: A Systematic ... Financial incentives are likely to be effective for substance use cessation. The evidence for this outcome is highly certain due to the homogeneity of study ...

6. withpower.com withpower.com/trial/phase-1-alcoholism-2022-7baba

Behavioral Treatment for Alcoholism and Tobacco Use Disorder Contingency Management is unique because it uses tangible rewards, like prizes, to encourage abstinence from alcohol and tobacco, making it different from other ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24793364/

Prize contingency management for smoking cessation - PubMed Results: Prize CM resulted in significant reductions in cigarette smoking relative to SC. These reductions were not apparent at follow-up. We ...