Contingency Management for Tobacco Use Disorder
(CM_TUD_Cancer Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Disqualifiers: Psychotic disorders, Bipolar, Neurocognitive, others
No Placebo Group
Approved in 2 Jurisdictions
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.12345
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.12367
How does the Contingency Management treatment for tobacco use disorder differ from other treatments?
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
I am a veteran aged 18 or older.
Active cigarette smoking within the past 24 months
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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.
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Trial 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 (Behavioral Intervention)
Trial OverviewThe 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
3Treatment groups
Experimental Treatment
Active Control
Group I: Focus GroupExperimental Treatment1 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 ManagementExperimental Treatment2 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 UsualActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
San Francisco VA Medical Center, San Francisco, CASan Francisco, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
University of California, San FranciscoCollaborator
References
Prize contingency management for smoking cessation: a randomized trial. [2022]Adjunctive behavioral smoking cessation treatments have the potential to improve outcomes beyond standard care. The present study had two aims: (1) compare standard care (SC) for smoking (four weeks of brief counseling and monitoring) to SC plus prize-based contingency management (CM), involving the chance to earn prizes on days with demonstrated smoking abstinence (carbon monoxide (CO) ≤6 ppm); and (2) compare the relative efficacy of two prize reinforcement schedules-one a traditional CM schedule, and the second an early enhanced CM schedule providing greater reinforcement magnitude in the initial week of treatment but equal overall reinforcement.
Incentives in smoking cessation: status of the field and implications for research and practice with pregnant smokers. [2006]We review the rationale and empirical evidence for the use of incentive and contingency management strategies for smoking cessation. Plausible theoretical rationales exist for the application of these strategies to smoking cessation, and a great deal of research with illicit drug users in laboratory or controlled treatment settings suggests such strategies can be effective. Contingency management methods have been effective in modifying smoking behavior in volunteers not seeking cessation assistance in highly controlled settings. Incentives have been used primarily as a component of worksite interventions, in community-wide quit-and-win programs, in quasiexperimental and experimental trials, and more recently with low-income pregnant women. Worksite studies have rarely been designed to isolate the impact of incentives. Nevertheless, they appear to be useful in these settings especially in increasing participation and increasing awareness about the deleterious effects of smoking. Quit-and-win programs are used widely in the United States and internationally and appear to attract many participants and produce modest quit rates. The quality of the evaluations of quit-and-win programs varies considerably, and none has employed rigorous control or comparison groups to sufficiently identify the effect of incentives. Recent controlled studies have yielded promising results with pregnant smokers, and larger trials are in progress. We discuss key methodological issues in mounting and evaluating incentive interventions, particularly during pregnancy, and discuss the practical and ethical issues arising from the use of incentives.
Examining implementation of contingency management in real-world settings. [2021]Very little is known about how reward programs are implemented in real-world substance use treatment settings and whether training in contingency management (CM), an empirically supported rewards-based intervention, impacts their design quality. Providers (N = 214) completed surveys assessing CM beliefs, training, and practices related to use of tangible rewards in treatment. For providers reporting they had not used rewards in treatment previously (54%, n = 116), we assessed beliefs about and interest in adopting a reward-based program. For those endorsing prior reward experience (46%, n = 98), we assessed the features and delivery of rewards and the relation of reward-based intervention training to 4 parameters related to CM efficacy: reinforcement magnitude, immediacy, frequency, and escalation. Among providers without reward experience, endorsement of supportive statements about CM predicted interest in adopting a rewards-based program. Providers with reward experience most often targeted treatment attendance and engaged in behaviors likely to decrease the effectiveness of the intervention, including use of low magnitudes (≤ $25/client), delayed reinforcement, failure to escalate reward values, and offering reward opportunities less than weekly. Providers with longer durations of training were more likely to engage in behaviors consistent with effective CM, including larger magnitude rewards and immediate delivery of rewards. Results indicate that real-world treatment clinics are using reward-based programs but not in ways consistent with research protocols. Longer training exposure is associated with greater adherence to some aspects of CM protocol design. Other evidence-based design features are not being implemented as recommended, even with training. (PsycINFO Database Record (c) 2020 APA, all rights reserved).
Greater perceived importance of earning abstinence-contingent incentives is associated with smoking cessation among socioeconomically disadvantaged adults. [2022]Individuals' perceptions of the importance of earning financial incentives for smoking cessation may influence the effectiveness of contingency management interventions. This study prospectively explored the perceived importance of earning financial incentives for smoking cessation and its association with smoking cessation within a contingency management intervention among socioeconomically disadvantaged adults.
The relative contribution of economic valence to contingency management efficacy: a pilot study. [2021]We investigated the extent to which a contingency management (CM) procedure that deducted money from a grand total available at the end of the study compared to a procedure in which money accumulated with continued abstinence from cigarette smoking. Results suggested that the procedure in which money increased contingent on abstinence resulted in a significantly greater likelihood of obtaining a clinically relevant (i.e., 48-hr) period of abstinence. In terms of attendance, participants in the condition in which monetary reinforcement accrued with consecutive instances of abstinence were significantly less likely to miss consecutive appointments than those in which money was deducted for failure to abstain.
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]The heaviest smoking and burden of tobacco-related illness occurs among low-income individuals. Using a behavioural economics framework, this non-randomised pilot study examined the preliminary efficacy of behavioural activation (BA) with a contingency management (CM) component designed to encourage continued use of BA skills and reductions in cigarettes smoked. Eighty-four participants were recruited from a community centre. Data were collected at the start of every other group and at four different follow-up time points. Domains assessed included number of cigarettes smoked, activity level, and environmental rewards (i.e. alternative environmental reinforcers). Over time, cigarette smoking decreased (p
Internet-based self-tailored deposit contracts to promote smoking reduction and abstinence. [2018]Deposit contracting may reduce costs and increase efficacy in contingency management interventions. We evaluated two Internet-based deposit contract arrangements for smoking. In Experiment 1, nine participants deposited self-selected amounts that could be earned back for meeting goals. During treatment, participants were reimbursed for breath samples with less than or equal to 6 parts per million carbon monoxide and met the criterion for 47% of samples compared to 1% during baseline. In Experiment 2, 10 participants' deposits were matched up to $50. No samples met the criterion during baseline but 41.5% met it during treatment. The average deposit was $82 in Experiment 1 and $49 in Experiment 2. Participants rated the intervention favorably and sample submission rates were high. These experiments suggest that Internet-based self-tailored deposits are acceptable, feasible, and can promote brief reduction and abstinence in some smokers. Future research should investigate individual and intervention factors that affect long-term cessation and uptake of deposit contracts.
Vouchers versus prizes: contingency management treatment of substance abusers in community settings. [2016]Contingency management (CM) interventions usually use vouchers as reinforcers, but a new technique awards chances of winning prizes. This study compares these approaches. In community treatment centers, 142 cocaine- or heroin-dependent outpatients were randomly assigned to standard treatment (ST), ST with vouchers, or ST with prizes for 12 weeks. CM patients remained in treatment longer and achieved greater durations of objectively confirmed abstinence than did ST patients; CM conditions did not differ significantly. Although abstinence at 6- and 9-month follow-ups did not differ by group, the best predictor of abstinence was longest duration of abstinence achieved during treatment. Thus, prize and voucher CM systems are equally efficacious in promoting long durations of abstinence, which in turn are associated with benefits posttreatment.
Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]Contingency management (CM) is a highly efficacious psychosocial treatment for substance use disorders based on the principles of behavioral analysis. CM involves delivering a tangible positive reinforcer following objective evidence of submission of a drug-negative urine sample. Although CM interventions primarily involve applying extrinsic rewards, a patient's intrinsic motivation to change substance use behavior may also be impacted by CM. This chapter provides an introduction to CM interventions for substance use disorders and examines the impact of CM on intrinsic motivation . It also addresses applications of this intervention to other conditions and patient populations.
Contingency management for treatment of substance abuse. [2019]Clinical research trials demonstrate the efficacy of contingency management procedures in treating substance use disorders. Usually, reinforcement, in the form of vouchers exchangeable for retail goods and services, is provided for drug abstinence in patients treated in psychosocial or methadone maintenance clinics. Recently, the types of reinforcers have been adapted to include lower cost alternatives, and reinforcement is being expanded to alter other target behaviors such as attendance at treatment, adherence to treatment goals, and compliance with medication. This chapter provides an overview of the populations and behaviors to which contingency management approaches have been applied. It also reviews design features that appear critical in the successful adaptation of the techniques. In addition, areas for future research are described.