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

532 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the proposed project is to evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely benefit from financial incentives for smoking cessation. The investigators have previously combined technologies including 1) portable carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm participant identity during breath sample submissions, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported abstinence. This automated CM approach will be evaluated in a randomized controlled trial that includes 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to either telephone counseling and nicotine replacement therapy (standard care \[SC\]) or SC plus a mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 26 weeks after a scheduled quit attempt. Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit will be the primary outcome variable. Cost-effectiveness will be evaluated to inform policy-related decisions. Potential mobile CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future versions of the intervention.

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 data supports the effectiveness of the treatment Mobile Contingency Management for Smoking Cessation?

Research shows that contingency management (CM), including mobile CM, is effective in helping people quit smoking, especially among those with substance use disorders and difficult-to-treat populations. Studies have found that CM can improve smoking cessation outcomes when combined with other treatments like cognitive-behavioral therapy (CBT) and standard care. ^{1 2 3 4 5}

Is mobile contingency management for smoking cessation safe for humans?

The research does not specifically mention safety concerns for mobile contingency management (CM) in smoking cessation, suggesting it is generally considered safe for use in humans. ^{1 2 3 5 6}

How is the Mobile Contingency Management treatment for smoking cessation different from other treatments?

Mobile Contingency Management (mCM) is unique because it uses a smartphone app to remotely monitor smoking behavior and deliver rewards for abstinence, making it a low-cost and accessible option compared to traditional in-person methods. This approach is particularly beneficial for populations with limited access to healthcare facilities, such as homeless veterans, and has shown promising results in increasing smoking cessation rates. ^{1 2 3 5 7}

Research Team

Darla E. Kendzor, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Contingency management for smoking cessation among treatment-seeking patients in a community setting. [2022]

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

Multicomponent smoking cessation treatment including mobile contingency management in homeless veterans. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of contingency management for smoking cessation in substance use treatment patients. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Prize contingency management for smoking cessation: a randomized trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis. [2021]

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

A systematic review of remotely delivered contingency management treatment for substance use. [2023]

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

Mobile health contingency management for smoking cessation among veterans experiencing homelessness: A comparative effectiveness trial. [2023]