Support Programs for Nicotine Addiction

(YouthCAT Trial)

Overseen By Erin Melley

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Must not be taking: Smoking cessation medications

Disqualifiers: Unstable medical, psychiatric, pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how tobacco and cannabis use affect each other during nicotine cessation. Participants will receive support to quit nicotine through programs such as counseling, text-based guidance, and incentives (known as contingency management) over 12 weeks. It suits individuals aged 18-25 who regularly use nicotine products like cigarettes or vapes, have frequently used cannabis, and wish to quit nicotine. Conducted entirely remotely, the study requires no in-person visits. As an unphased trial, it offers a unique opportunity to contribute to understanding the relationship between tobacco and cannabis use, potentially benefiting future cessation programs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that help with quitting smoking.

What prior data suggests that these support programs are safe for participants?

Research shows that the treatments in this study—contingency management, counseling, and text-based support—are generally easy for people to handle.

Contingency management safely and effectively helps people quit smoking by providing rewards when they prove they haven't smoked. Many places have used this method successfully without major safety concerns.

Counseling, another treatment in this study, has been shown by research to effectively help people quit smoking through both one-on-one and group sessions, with no major safety issues reported.

Text-based support is also part of this study. Studies show that sending supportive text messages can aid in quitting smoking. This method is simple to use and has not been linked to any significant safety problems.

Overall, these treatments have been used successfully in many studies and are considered safe for helping people quit smoking and vaping. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for nicotine addiction because they combine different support strategies that address both the physical and behavioral aspects of addiction. Contingency management offers incentives to encourage quitting, which is a novel approach compared to traditional methods that often rely heavily on medication or therapy alone. Counseling provides personalized support and guidance, helping individuals understand and overcome their addiction triggers. Lastly, text-based support offers a convenient, accessible way to receive encouragement and resources, making it easier for people to stay motivated and connected throughout their quitting journey. Together, these components offer a comprehensive and flexible approach that could enhance the effectiveness of nicotine addiction treatment.

What evidence suggests that this trial's treatments could be effective for nicotine addiction?

Research has shown that contingency management, which involves rewarding individuals for not smoking, can significantly reduce smoking during treatment. Some studies found that 2.22% to 4.12% of participants remained smoke-free a year later, which is encouraging. Counseling also effectively aids smoking cessation, especially when combined with treatments like nicotine patches. Additionally, support through text messages has increased the chances of quitting. For instance, a text message program made teens 35% more likely to stop vaping. This trial will explore these various support programs, offering different ways to help people quit smoking. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 who regularly use tobacco (smoke or vape) and cannabis. They must want to quit nicotine but not necessarily cannabis, have used nicotine products on most days in the past 3 months, and used cannabis frequently in the last month. Participants will provide samples to confirm usage.

Inclusion Criteria

Must report use of cannabis on at least 10 out of the past 30 days

I have used nicotine or tobacco products almost daily for the last 3 months.

Must submit a positive instant-read, oral fluid cotinine sample prior to enrollment

Exclusion Criteria

Immediate interest in cannabis cessation or treatment

Any significant or acutely unstable medical, psychiatric, or substance use problem that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation

Pregnant (self-report) or trying to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nicotine cessation treatment including remote contingency management, text-based resources, and counseling for 12 weeks

12 weeks

Remote procedures, no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contingency management
• Counseling
• Text-based support

Trial Overview The study aims to understand how quitting tobacco/nicotine affects cannabis use. It includes a 12-week cessation treatment with counseling, rewards for staying off nicotine, and text support. No need for in-person visits as all procedures are remote through the Medical University of South Carolina.

How Is the Trial Designed?

Group I: Nicotine treatment Experimental Treatment 3 Interventions

All participants recieve active nicotine treatment for 12 weeks.

Contingency management is already approved in United States, European Union for the following indications:

Approved in United States as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Approved in European Union as Contingency Management for:

• Alcohol dependence
• Substance use disorders

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Contingency management (CM) significantly improves smoking abstinence rates among individuals with substance use disorders, showing a relative risk of 2.555 compared to control groups at the end of treatment, based on a meta-analysis of 22 studies.

While CM is effective in promoting smoking cessation immediately after treatment, its long-term effects on maintaining abstinence do not show significant advantages over other treatment methods, indicating that additional strategies may be needed for sustained recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of contingency management for smoking cessation in substance users: A systematic review and meta-analysis. Secades-Villa, R., Aonso-Diego, G., García-Pérez, Á., et al.[2021]

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]

Contingency management (CM) has been effectively implemented at a large U.S. Department of Veterans Affairs Addiction Treatment Center to encourage abstinence from substance use, highlighting its role as an evidence-based intervention.

The implementation faced challenges such as staff acceptance, initial referral limitations, and the need for proper training and resources, but local innovations have helped expand CM since its introduction in 2012.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Contingency Management at a Large VA Addiction Treatment Center. Ruan, H., Bullock, CL., Reger, GM.[2018]

A group-based contingency management (CM) intervention for HIV-positive patients with cocaine or opioid use disorders led to significantly more consecutive drug-free urine samples compared to a 12-step (TS) group, indicating its effectiveness in promoting abstinence during treatment.

CM participants also experienced greater reductions in viral loads and HIV-risk behaviors from pre- to post-treatment, although these benefits were not sustained in the long term, highlighting the need for further research to enhance lasting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group-based randomized trial of contingencies for health and abstinence in HIV patients. Petry, NM., Weinstock, J., Alessi, SM., et al.[2021]

Contingency management (CM) interventions have been shown to consistently improve treatment outcomes for substance abuse, but they are rarely used in practice due to various concerns.

The article reviews common criticisms of CM, including philosophical, motivational, durability, and economic issues, and suggests ways to address these concerns to enhance the implementation of this effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? Petry, NM., Alessi, SM., Olmstead, TA., et al.[2019]

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]

In a study of 94 smokers, an internet-based contingency management program that provided financial incentives for verified abstinence significantly increased short-term smoking cessation rates at 4 weeks (39.6% abstinence) compared to a control group (13.0% abstinence).

While the initial benefits of the incentive program diminished over time, with no significant differences at 3 and 6 months, the program was well-received, particularly for its ease of use and the financial rewards, indicating its potential as an effective tool for promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. Dallery, J., Raiff, BR., Kim, SJ., et al.[2022]

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]

Contingency management (CM) interventions have been shown to effectively increase physical activity and medication adherence in various medical conditions, based on a review of 24 randomized studies.

The positive effects of CM tend to diminish once the reinforcement is removed, indicating the need for ongoing support to maintain these health behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management for individuals with chronic health conditions: A systematic review and meta-analysis of randomized controlled trials. Ellis, JD., Struble, CA., Fodor, MC., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5020416/

Prize Contingency Management for Smoking Cessation Our findings reveal that prize CM leads to significant reductions in smoking during treatment relative to a control intervention, but the benefits did not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9157212/

A randomized controlled trial of contingency management ... Smoking abstinence outcomes were superior compared to other CM studies, which informed on 2.22% - 4.12% of tobacco abstinence rates at 12-month follow-up ( ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306460321001052

Contingency management for smoking cessation among ... This study aims to examine the effect of CM on smoking outcomes and in-treatment behaviors (i.e., retention, session attendance and adherence to nicotine use ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1207955/full

Tobacco treatment incorporating contingency management ... This study evaluated the feasibility and acceptability of a non–face-to-face delivery of tobacco treatment incorporating a novel combination of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211335523002024

Mobile health contingency management for smoking ... Contingency management (CM) may be a cost-effective way to maximize smoking cessation efficacy among veterans experiencing homelessness. CM is a behavioral ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9514803/

Mobile Contingency Management for Smoking Cessation ... This automated CM approach will be evaluated in a randomized controlled trial of 532 low-income adults seeking cessation treatment. Participants will be ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7153483/

Technology-based contingency management and e ... This study assessed the effects of CM and electronic cigarettes (ECs) on smoking reductions and abstinence for durations of 30-36 days.

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0278870

Contingency management to promote smoking cessation in ... Contingency management (CM) is a strategy that has shown considerable efficacy for smoking cessation and has been used in short-term studies of ...

9. library.samhsa.gov library.samhsa.gov/sites/default/files/contingency-management-advisory-pep24-06-001.pdf

contingency-management-advisory-pep24-06-001.pdf Contingency management (CM) is a proven health care intervention with demonstrated effectiveness in treating a variety of substance use disorders (SUDs) ...