Contingency Management for Tobacco Use Disorder

(CM_Surgery Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ellen Herbst, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Psychotic disorders, Bipolar, Neurocognitive, others

No Placebo Group

Approved in 2 Jurisdictions

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

Trial 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 (Behavioral Intervention)

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

San Francisco VA Health Care System San Francisco, CA

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2636

Patients Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Patients Recruited

26,300+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]