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

Trial Summary

What is the purpose of this trial?

The goal of this study is to design and test the first mobile contingency management (CM) smoking cessation intervention for military Veterans undergoing major elective surgery. Smoking is the leading risk factor for postoperative complications and is associated with longer hospital stays, reoperations, and 30-day mortality. Smoking rates among patients undergoing major elective surgery are high, 22.3-43.0%. It is imperative to identify efficacious, strategically timed smoking cessation interventions for surgery patients. CM incentivizes smoking cessation through positive reinforcement (rewards) when bioverified abstinence is achieved. To ensure feasibility, CM must be tailored to the clinical context. CM for smoking cessation has never been delivered before and after major surgery, nor has mobile CM bioverification been trialed perioperatively. The investigators will develop and test a tailored mobile smoking cessation CM protocol for Veterans undergoing major elective surgery.

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 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 by encouraging them to stay smoke-free. Studies have found that offering prizes or money for not smoking can increase the chances of quitting, especially when the rewards are given immediately and are of higher value. ^{1 2 3 4 5}

Is contingency management safe for humans?

Contingency management, which uses rewards to encourage behavior change, has been studied in various settings and is generally considered 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 Health Care System

Eligibility Criteria

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

Enrollment in end of life/palliative care

Timeline

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

Treatment Details

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.

Participant Groups

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+

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 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]

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]

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 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]

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

A preliminary investigation of schedule parameters on cocaine abstinence in contingency management. [2023]

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

Contingency management for treatment of substance abuse. [2019]

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

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

10. Germany pubmed.ncbi.nlm.nih.gov

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