Mobile Contingency Management for Smoking Cessation

(P3 Trial)

Overseen By Darla Kendzor, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Nicotine replacement

Disqualifiers: High income, Low literacy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people quit smoking by testing a new approach that combines standard care with mobile financial incentives. Participants can earn rewards through an automated system called Automated Mobile Contingency Management (CM), which uses mobile phones and carbon monoxide monitors to confirm they haven't smoked. This trial specifically targets individuals who smoke at least five cigarettes daily, have a low income, and are ready to quit soon. The goal is to determine if this method is effective and cost-efficient, potentially improving future smoking cessation programs. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance smoking cessation strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must be willing to quit smoking and abstain from smoking cannabis and other tobacco products.

What prior data suggests that this mobile contingency management approach is safe for smoking cessation?

Research has shown that automated mobile systems to aid smoking cessation are generally well-received. Studies have found that providing financial rewards via mobile phones for not smoking can effectively support quitting. Importantly, these studies did not identify any serious safety issues. Participants used portable devices to verify their non-smoking status, and the technology proved safe.

This trial is in the "Not Applicable" phase, focusing on system functionality rather than safety testing. However, similar methods in past studies have not demonstrated any serious side effects, indicating a positive safety profile. The system complements standard care, such as phone counseling and nicotine patches, which are common and safe methods to assist smoking cessation.

In summary, the automated mobile system appears to be a safe method to help people quit smoking. It employs proven technology and methods without known serious risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Contingency Management (CM) for smoking cessation because it combines standard care with small financial incentives for quitting smoking, verified through biochemical tests. This approach is innovative because it adds a motivational component that rewards individuals for their progress, potentially enhancing their commitment to quitting. Unlike traditional methods, which often rely solely on counseling and medication, this technique leverages positive reinforcement, making the quitting process more engaging and encouraging.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Studies have shown that contingency management (CM), a treatment in this trial, can help people quit smoking by offering small financial rewards for remaining smoke-free. Research indicates this method is cost-effective, particularly for groups like homeless veterans. In this trial, some participants will receive CM combined with standard care, including counseling and nicotine patches, enhancing its effectiveness. Mobile technology offers a low-cost way to deliver this method, increasing accessibility. This approach has been tested in various groups and shows promise in helping them quit successfully. ^{1 2 6 7 8}

Who Is on the Research Team?

Darla E. Kendzor, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke at least 5 cigarettes daily, want to quit within 7-14 days after joining, and earn below a certain income level. They must not use other tobacco products or have conditions that prevent using nicotine replacement therapy (NRT). A valid ID and U.S. residence proof are required.

Inclusion Criteria

You smoke at least 5 cigarettes every day.

I can provide proof of my identity and that I live in the U.S.

have a CO level of >6 ppm

Exclusion Criteria

do not meet the specified inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care with telephone counseling and nicotine replacement therapy or standard care plus a 12-week smartphone-based financial incentives intervention for smoking cessation

12 weeks

Follow-up

Participants are monitored for smoking abstinence and cost-effectiveness for 26 weeks after the scheduled quit attempt

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Automated Mobile Contingency Management (CM)
• Standard Care (SC)

Trial Overview

The study tests an automated mobile phone system offering financial rewards for quitting smoking against standard care with telephone counseling and NRT. Participants' success in quitting will be tracked by remote breath tests confirming no smoking.

How Is the Trial Designed?

Group I: Contingency Management (CM) Experimental Treatment 2 Interventions

CM participants will receive standard care in addition to small financial incentives for biochemically-verified abstinence.

Group II: Standard Care (SC) Active Control 1 Intervention

Participants randomized to Standard Care will be offered weekly smoking cessation counseling and pharmacotherapy.

Automated Mobile Contingency Management (CM) is already approved in United States for the following indications:

Approved in United States as Mobile Contingency Management for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

Mobile telephone-delivered contingency management (CM) interventions significantly improve abstinence rates from tobacco and alcohol compared to control conditions, based on a systematic review of seven studies involving 222 participants.

The meta-analysis showed strong effect sizes for various outcomes, including a 94% increase in the percentage of negative samples and a 108% increase in the longest duration of abstinence, indicating that this low-cost approach can effectively support individuals with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis. Getty, CA., Morande, A., Lynskey, M., et al.[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 pilot study involving 20 homeless veteran smokers showed that a smartphone-based contingency management (mCM) approach, combined with counseling and nicotine replacement, achieved a 50% smoking abstinence rate at 4 weeks, indicating its potential effectiveness.

Participants in the study earned an average of $286 in incentives, demonstrating high compliance with the mCM program, which suggests that financial incentives can motivate smoking cessation efforts in hard-to-reach populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent smoking cessation treatment including mobile contingency management in homeless veterans. Carpenter, VL., Hertzberg, JS., Kirby, AC., et al.[2022]

Contingency management (CM) significantly improved tobacco abstinence rates when added to cognitive-behavioral treatment (CBT) for smoking cessation in a study of 80 participants, indicating its effectiveness in the short term.

However, the benefits of CM diminished after treatment ended, and quitting smoking did not negatively impact abstinence from other substances, suggesting that smoking cessation does not jeopardize recovery from substance use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of contingency management for smoking cessation in substance use treatment patients. Secades-Villa, R., Aonso-Diego, G., González-Roz, A.[2022]

In a study of 92 treatment-seeking patients, combining contingency management (CM) with cognitive-behavioral treatment (CBT) significantly improved smoking cessation rates, with 95.3% achieving abstinence post-treatment compared to 59.2% in the CBT-only group.

The combination of CBT and CM also led to higher long-term abstinence rates, with 51.2% maintaining abstinence at six months, compared to 28.6% in the CBT group, demonstrating the effectiveness and feasibility of this approach in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among treatment-seeking patients in a community setting. Secades-Villa, R., García-Rodríguez, O., López-Núñez, C., et al.[2022]

Remote delivery of contingency management (CM) for substance use treatment has been shown to improve outcomes such as abstinence and engagement in treatment, similar to in-person CM, based on a systematic review of 39 studies.

The majority of these studies (57.5%) were of strong quality, indicating that remote CM is not only feasible across various digital platforms but also effective in reducing barriers to treatment access for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of remotely delivered contingency management treatment for substance use. Coughlin, LN., Salino, S., Jennings, C., et al.[2023]

A study involving 127 homeless veterans showed that mobile contingency management (mCM) significantly increased the likelihood of prolonged tobacco abstinence at the 6-month follow-up, with participants having 3.1 times higher odds of quitting compared to standard care.

While mCM was found to be cost-effective, with an increase of one quality-adjusted life year saved for an additional cost of $1,133, the effectiveness diminished by the 12-month follow-up, highlighting the need for ongoing support to maintain abstinence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health contingency management for smoking cessation among veterans experiencing homelessness: A comparative effectiveness trial. Wilson, SM., Blalock, DV., Young, JR., et al.[2023]

Citations

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