Contingency Management + Cognitive Behavioral Therapy for Quitting Vaping

Overseen By Thomas Liss, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychoactive drugs

Disqualifiers: Substance use dependence, Psychosis, Major depression, Panic disorder, others

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program can help teenagers stop vaping nicotine. The program combines earning rewards for quitting (contingency management, or CM) with online counseling sessions (cognitive behavioral therapy). Participants are divided into two groups: one earns more money for negative nicotine tests, while the other earns money simply for taking the test. High school students who regularly vape nicotine and want to quit might be a good fit for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could shape future programs for teenagers seeking to quit vaping.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using psychoactive drugs like anxiolytics or antidepressants, you must have been on them consistently for 2 months, and your condition should be stable and monitored by a doctor.

What prior data suggests that this intervention is safe for teenagers?

Research has shown that remote contingency management (CM) is a safe and well-accepted method to help individuals quit substances like nicotine. Studies have found this approach practical and agreeable for those aiming to reduce or stop their use. It works by offering rewards to encourage behaviors like staying nicotine-free, confirmed through tests.

No specific reports of serious side effects have emerged with this treatment. Instead, the focus remains on its effectiveness in helping people quit vaping, suggesting that the treatment is generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Contingency Management and Cognitive Behavioral Therapy for quitting vaping because it offers a fresh approach to tackling nicotine addiction. Unlike standard treatments like nicotine replacement therapies or medications that target withdrawal symptoms, this method incentivizes abstinence through a rewards system for negative nicotine tests. By leveraging financial incentives and cognitive strategies, this approach aims to motivate individuals to stay vape-free, potentially offering a more engaging and supportive pathway to quitting.

What evidence suggests that this trial's treatments could be effective for quitting vaping?

Research has shown that giving rewards for quitting, known as contingency management (CM), can help people stop vaping. In this trial, participants in the Remote Contingency Management (CM) arm will receive increasing payments for each negative saliva cotinine test. One study found that nearly half of the young adults who participated quit vaping after three months with help from a quitline service. Another study showed that participants felt more confident about quitting vaping after using a mobile CM program for 12 weeks. Additionally, a review found that remote CM can assist those trying to reduce substance use, including vaping. These findings suggest that CM could effectively help teenagers quit vaping nicotine. ^{1 6 7 8 9}

Who Is on the Research Team?

Suchitra Krishnan-Sarin, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for high school students aged 13-19 who regularly use e-cigarettes with nicotine and want to quit. They must be able to read and write, have no major mental health issues untreated, not use psychoactive drugs or antidepressants unless stable and monitored, not pregnant or lactating, and without substance dependence except mild cannabis use.

Inclusion Criteria

I use e-cigarettes regularly and want to quit.

Able to read and write

Does not meeting criteria for dependence on other psychoactive substances, psychosis, major depression or panic disorder based on psychological evaluation.

Exclusion Criteria

I do not have psychosis or a high risk of harming myself or others.

I've been on stable doses of my mental health meds for over 2 months.

Currently enrolled in, or planning to enroll in any other behavioral or pharmacological treatments for cessation of nicotine or vaping

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week Remote Contingency Management intervention with weekly CBT sessions

4 weeks

4 weekly sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up appointments

12 months

Follow-up at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Remote Contingency Management (CM) for nicotine abstinence

Trial Overview The study tests a new program combining rewards (contingency management) with online video counseling (cognitive behavioral therapy) to help teenagers stop vaping. Participants will either receive this intervention or be in a control group that does not receive the treatment.

How Is the Trial Designed?

Group I: Remote Contingency Management (CM) for nicotine abstinence Experimental Treatment 1 Intervention

Participants will be paid increasing amounts of payment for each negative saliva cotinine test.

Group II: Control Placebo Group 1 Intervention

Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

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) 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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885867/

A pilot feasibility study of a behavioral intervention for ... Outcomes suggest that CM for young adult vaping cessation, delivered via telehealth, is a worthwhile intervention to further adapt and properly evaluate in a ...

2. formative.jmir.org formative.jmir.org/2024/1/e57376

Outcomes of a Comprehensive Mobile Vaping Cessation ... From baseline to 12 weeks, participants reported substantial improvement in their confidence to quit vaping and maintain their quit status ( ...

3. ajpmonline.org ajpmonline.org/article/S0749-3797(24)00371-4/fulltext

Quitline-Based Young Adult Vaping Cessation This quitline-delivered intervention was successful at helping young adults quit vaping, with almost half abstinent after 3 months.

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

Mobile health contingency management for smoking ... This study provides evidence that CM has short-term effectiveness for smoking abstinence among veterans experiencing homelessness. However, abstinence rates ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10936237/

A systematic review of remotely delivered contingency ... Remotely delivered CM focusing on abstinence or use reduction from substances or engagement in substance use treatment services improves outcomes at the end of ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875923000279

A systematic review of remotely delivered contingency ... Digital contingency management entails remote methods to obtain biochemical confirmation of drug status and provide desirable, tangible consequences contingent ...

7. jsatjournal.com jsatjournal.com/article/S2949-8759(23)00027-9/abstract

A systematic review of remotely delivered contingency ... Remotely delivered contingency management is feasible and acceptable for substance use treatment. •. Remotely delivered contingency ...

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

Mobile Contingency Management for Smoking Cessation ... The current study will evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely earn ...

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

Tobacco treatment incorporating contingency management ... Contingency management is a behavioral therapy that provides financial or prize-based incentives in return for biochemically verified abstinence ...