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

Trial Summary

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 data supports the effectiveness of the treatment Contingency Management for nicotine addiction?

Research shows that Contingency Management (CM) is effective in helping people quit smoking, especially when combined with cognitive-behavioral therapy (CBT). CM has been successful in promoting abstinence from smoking and other substance use by providing rewards for positive behavior changes. ^{1 2 3 4 5}

Is Contingency Management safe for humans?

Contingency Management (CM) is generally considered safe for humans, as it is a behavioral intervention that uses positive reinforcement to encourage desired behaviors, such as abstinence from substance use. The research does not report any safety concerns related to its use. ^{1 3 4 6 7}

How is the treatment 'Contingency Management, Counseling, Text-based support' unique for nicotine addiction?

This treatment is unique because it uses contingency management (CM), which involves rewarding positive behavior like not smoking, and is often combined with counseling and text-based support to help people quit smoking. Unlike many traditional methods, CM has shown effectiveness in promoting smoking cessation, especially among those with substance use disorders, and can be delivered through internet-based platforms, making it more accessible. ^{1 2 4 8 9}

What is the purpose of this trial?

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Eligibility Criteria

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

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

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

I want to quit using nicotine products.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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 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) 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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

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

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

Group-based randomized trial of contingencies for health and abstinence in HIV patients. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Motivation and Contingency Management Treatments for Substance Use Disorders. [2016]

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

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

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

Contingency management for individuals with chronic health conditions: A systematic review and meta-analysis of randomized controlled trials. [2021]

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

Implementation of Contingency Management at a Large VA Addiction Treatment Center. [2018]

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

Contingency management treatment for substance use disorders: How far has it come, and where does it need to go? [2019]

8. England pubmed.ncbi.nlm.nih.gov

Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. [2022]

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

Effectiveness of contingency management for smoking cessation in substance users: A systematic review and meta-analysis. [2021]