Reat ETM and Hypothetical ETM for Smoking/Cigarette Smoking

Overseen By Roberta Freitas Lemos, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Smoking cessation medications

Disqualifiers: Uncontrolled conditions, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two procedures, in-lab and remote, in studying cigarette smoking habits. It will compare real and hypothetical scenarios to understand smokers' purchase decisions. The study seeks individuals who smoke at least five cigarettes daily and have maintained stable smoking habits for at least three months, with infrequent use of other tobacco products. Participants must have a computer and internet access to join the study. As an Early Phase 1 trial, this research focuses on understanding these procedures in people, offering participants a chance to contribute to groundbreaking insights on smoking behavior.

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've used smoking cessation medications in the past 30 days.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Reat ETM and Hypothetical ETM are under study to determine their effectiveness in helping people reduce smoking. As these treatments are in the early testing stages, limited safety information is available.

In early trials like this, the primary goal is to assess the treatment's safety and the body's response. Typically, researchers test these treatments on a small group to identify any major side effects. The safety details of Reat ETM and Hypothetical ETM are still under evaluation, so participants should be aware that not all side effects or risks may be known yet.

Prospective participants should discuss any concerns with the study team and gather as much information as possible about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking because they offer innovative approaches compared to current options like nicotine replacement therapy, medications such as varenicline and bupropion, and behavioral therapies. The Hypothetical ETM and Reat ETM treatments might involve unique mechanisms or delivery methods that could enhance their effectiveness in helping people quit smoking. These experimental treatments could provide new insights into smoking cessation by targeting different aspects of nicotine addiction or providing more convenient access to treatment through in-lab or remote procedures. This could potentially lead to more personalized and accessible smoking cessation options for individuals struggling to quit.

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

Research has shown that evidence-based treatments can help people quit smoking, but many still struggle with relapse. In this trial, participants will join either the Reat ETM or Hypothetical ETM treatment arms. These treatments mimic real-world markets, where stories can influence purchasing decisions. Such stories have shown promise in reducing regular cigarette purchases and increasing e-cigarette purchases. This suggests they might help smokers switch from traditional cigarettes. Early results indicate these methods could aid in quitting smoking, but further research is needed to confirm their long-term success. ^{1 4 6 7 8}

Who Is on the Research Team?

Roberta Freitas-Lemos, Ph.D.

Principal Investigator

Fralin Biomedical Research Institute at VTC

Are You a Good Fit for This Trial?

This trial is for individuals who are at least 21 years old, have been smoking consistently for the past three months, and smoke a minimum of five cigarettes daily. They must not use other tobacco products often, be able to give informed consent, and have internet access. People with uncontrolled health issues or those planning to quit smoking soon cannot participate.

Inclusion Criteria

Provide informed consent

I am 21 years old or older.

Use other tobacco products less than weekly

Exclusion Criteria

I have used smoking cessation aids in the last 30 days.

I do not have any uncontrolled health conditions like diabetes or high blood pressure.

I plan to quit or change my tobacco use within the next 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Procedures

Participants complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price, under in-lab or remote conditions.

1 day

1 visit (in-person or remote)

Follow-up

Participants are monitored for safety and effectiveness after completing the ETM trials

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hypothetical ETM
• Reat ETM

Trial Overview The study is examining two methods related to cigarette smoking: in-lab and remote procedures using both hypothetical and real ETM (presumably a measure related to tobacco use) purchase outcomes. It aims to see if these different settings yield comparable results.

How Is the Trial Designed?

Group I: Remote procedures Experimental Treatment 2 Interventions

Exclusive cigarette smokers will be recruited and will experience all study procedures remotely.

Group II: In-lab procedures Experimental Treatment 2 Interventions

Exclusive cigarette smokers will be recruited and will experience all study procedures in the laboratory.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Published Research Related to This Trial

A study of 366 quit attempters using nicotine replacement therapy (NRT) found that many users discontinue treatment prematurely, primarily due to resuming smoking (34%) and experiencing side effects (17%).

Factors such as poverty, age, and minority status were linked to higher rates of discontinuation, suggesting that tailored interventions could improve compliance and enhance the effectiveness of NRT in helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation of nicotine replacement therapy among smoking-cessation attempters. Burns, EK., Levinson, AH.[2022]

Increased reduction in cigarettes per day (CPD) is associated with higher odds of smoking cessation, as shown in 5 out of 7 intervention trials and 3 out of 4 naturalistic studies, indicating that reducing smoking can be an effective strategy for quitting.

Every 1% decrease in CPD correlates with a 3% to 4% increase in cessation odds, and naturalistic studies suggest that larger reductions can lead to increases in cessation odds ranging from 50% to 290%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Magnitude of Reduction in Cigarettes Per Day Predict Smoking Cessation? A Qualitative Review. Klemperer, EM., Hughes, JR.[2022]

In a 12-week pilot study involving residential substance abuse treatment patients, those receiving prize contingency management for smoking cessation showed significantly higher rates of smoking abstinence compared to those receiving standard care.

Contingency management led to a greater percentage of negative carbon monoxide tests and a higher number of consecutive negative tests, indicating its effectiveness in promoting smoking cessation among substance abusers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contingency management promotes smoking reductions in residential substance abuse patients. Alessi, SM., Petry, NM., Urso, J.[2021]

In a study of 88 treatment-seeking smokers, it was found that both alcohol and coffee consumption are linked to increased demand for cigarettes, indicating that these substances may reinforce smoking behavior.

The results suggest that interventions aimed at reducing alcohol and coffee intake could enhance the effectiveness of smoking cessation treatments, highlighting the importance of addressing these factors in smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of combined coffee and alcohol use over cigarette demand among treatment-seeking smokers. García-Pérez, Á., Weidberg, S., González-Roz, A., et al.[2020]

A study involving 161 cigarette smokers (90 in a training cohort and 71 in a validation cohort) found that delay discounting, or the tendency to favor smaller immediate rewards over larger delayed ones, is a strong predictor of success in quitting smoking after group cognitive-behavioral therapy (CBT).

The decision trees developed from this study improved the prediction of smoking cessation outcomes, correctly identifying 80% of participants' smoking status post-treatment and 81% at a 6-month follow-up, suggesting a potential for personalized treatment strategies in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Machine-Learning Approach to Predicting Smoking Cessation Treatment Outcomes. Coughlin, LN., Tegge, AN., Sheffer, CE., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-smoking-cigarette-7-2023-aa278

Reat ETM and Hypothetical ETM for Smoking/Cigarette ... The research suggests that evidence-based treatments improve the likelihood of quitting smoking, although many people still relapse.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037687161830677X

Narratives engage cognitive biases to increase electronic ... Narratives can decrease conventional cigarette and increase e-cigarette purchasing in an ETM that mimics real-world marketplaces.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10194042/

Predictors of smoking cessation outcomes identified by ... This systematic review aims to characterize the utility of machine learning to identify the predictors of smoking cessation outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06795997?cond=Tobacco&viewType=Table&rank=9

Tobacco/Nicotine Purchase Patterns Across SES Participants will complete a one session study including consent and behavioral tasks (ETM and smoking-related assessments). A Qualtrics survey will administer:.

5. researchgate.net researchgate.net/publication/328756452_The_Experimental_Tobacco_Marketplace_Narrative_Influence_on_Electronic_Cigarette_Substitution

Narrative Influence on Electronic Cigarette Substitution National data modelling suggests no reduction in cigarette smoking prevalence attributable to e-cigarette use in the USA among people aged ≥45.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6605101/

The Experimental Tobacco Marketplace - PMC Evidence suggests that ECs are primarily being used as a means to reduce and/or stop smoking cigarettes, but concerns suggest that EC availability and promotion ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0091743518301373

Electronic cigarette substitution in the experimental ... The Experimental Tobacco Marketplace (ETM) is an experimental online store. •. Extant ETM data on cigarette and e-cigarette substitution were reviewed.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11915159/

Observational studies of exposure to tobacco and nicotine ... Non-randomized observational studies can track risk-induction and -reduction associated with real-world use of non-combusted nicotine and tobacco products.