N/A
N=305
Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace
Substance-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02951143 ↗Enrolled (actual)
305
Serious AEs
2.0%
Results posted
Sep 2021
Primary outcome: Primary: Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task — 1.50; 1.45; 1.47; 1.45 Cigarettes (log transformed)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPECTRUM cigarettes (Drug); SPECTRUM cigarettes between (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Polytechnic Institute and State University
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task |
1.50; 1.45; 1.47; 1.45; 1.37; 1.35 | — |
| PRIMARY Change in Blood Nicotine Content Over the Course of the Session |
551.31; 350.62; 192.91; 57.11; 30.18; 6.24 | — |
| PRIMARY Experimental Marketplace Purchases |
4.07; 12.29; 15.25; 13.67; 15.25; 12.70 | — |
Summary
Tobacco regulatory policies can have unanticipated consequences; therefore, methods that would permit prospective estimates of the effects of potential tobacco regulations are necessary for the development of tobacco regulatory science. The goal of this project is to experimentally assess how smokers purchase and consume reduced-nicotine cigarettes. In experiment 1, we will investigate how purchasing/consuming reduced-nicotine cigarettes is related to nicotine content and absorption. In experiment 2, we will investigate how purchasing/consuming changes when other nicotine products are available in an experimental marketplace setting. The proposed projects can directly inform tobacco regulation by providing estimates of the real-world effects of novel policies.
Eligibility Criteria
Inclusion Criteria
- smoke at least 5 cigarettes per day
- have a breath carbon monoxide (CO) level of at least 10 ppm at intake
- no immediate plans to quit smoking.
Exclusion Criteria
- pregnant, lactating, plans to become pregnant
- weigh more than 110lbs (experiment 1 only)
- have plans to move out of the area during the course of the experiment
To see if you are eligible, use the following confidential link: http://vtcri.info/arrcclinicaltrials
Data sourced from ClinicalTrials.gov (NCT02951143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.