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

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

What data supports the effectiveness of the treatment Hypothetical ETM and Reat ETM for smoking cessation?

The research suggests that evidence-based treatments improve the likelihood of quitting smoking, although many people still relapse. Nicotine replacement therapy (NRT) is known to double the chances of quitting successfully, indicating that treatments targeting nicotine addiction can be effective. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial studies how smokers decide to buy cigarettes when prices increase.

Research Team

Roberta Freitas-Lemos, Ph.D.

Principal Investigator

Fralin Biomedical Research Institute at VTC

Eligibility Criteria

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.

Have stable tobacco use patterns for at least three months

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation of nicotine replacement therapy among smoking-cessation attempters. [2022]

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

Contingency management promotes smoking reductions in residential substance abuse patients. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A Machine-Learning Approach to Predicting Smoking Cessation Treatment Outcomes. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of combined coffee and alcohol use over cigarette demand among treatment-seeking smokers. [2020]