Testing the ETM: Examination and Comparison of Different Methods

Virginia Polytechnic Institute and State University

Status and phase: Completed; Early Phase 1

Conditions: Cigarette Smoking

Treatments: Drug: Hypothetical ETM; Drug: Reat ETM

Study type: Interventional

Funder types: Other

Identifiers

NCT05946031

IRB #24-837

Details and patient eligibility

About

This study will experimentally assess the comparability of in-lab and remote procedures with hypothetical and real ETM purchase outcomes.

Full description

In a between-group within-subject repeated measures design, participants will be randomly assigned to one of two procedures (in-lab or remote; between-group) and complete two conditions (real and hypothetical; within-subject), which include six trials assessing increasing cigarette prices.

Enrollment: 87 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provide informed consent
• Be at least 21 years of age or older
• Stable tobacco use patterns for at least three months
• Smoke at least 5 cigarettes daily
• Use other tobacco products less than weekly
• Have access to a computer and internet

Exclusion criteria

• report uncontrolled physical or mental health conditions (e.g., uncontrolled diabetes, high blood pressure, major depressive disorder, etc.),
• use of smoking cessation medications (e.g., nicotine replacement, bupropion, varenicline) in the past 30 days,
• report concrete, immediate plans to alter/quit using their usual tobacco products in the next 30 days,
• be pregnant or lactating

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

In-lab procedures

Experimental group

Description:

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

Treatment:

Drug: Reat ETM

Drug: Hypothetical ETM

Remote procedures

Experimental group

Description:

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

Treatment:

Drug: Reat ETM

Drug: Hypothetical ETM