Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace

Not Applicable

Completed

• Conditions: Substance-Related Disorders
• Interventions: Drug: SPECTRUM cigarettes; Drug: SPECTRUM cigarettes between

• Registration Number: NCT02951143
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief 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.

Detailed Description

The specific objective in Experiment 1 is to examine the effect of nicotine content (0.4 mg/g, 1.4 mg/g, 2.5 mg/g, 5.6 mg/g, and 17.4 mg/g of tobacco) and blood nicotine absorption on laboratory behavioral economic measures of demand intensity and elasticity. Under double-blind conditions, we will examine the relationship between plasma nicotine and cigarette demand as a function of the dose of the nicotine in the cigarettes. Regular cigarette smokers will consume, on separate sessions, controlled puffs of a cigarette containing a blinded dose of nicotine then complete a cigarette purchase task, our measure of value, while plasma nicotine is measured. We hypothesize that cigarette demand will be associated with dose and level of circulating nicotine, but in a nonlinear fashion such that consumption of very low dose cigarettes will not be predicted by nicotine dose or intake alone.

To inform how various products may interact, we have developed and tested a novel method called the Experimental Tobacco Marketplace. The Experimental Tobacco Marketplace is a systematic extension of similar marketplace methods used with other consumer products (e.g., food marketplaces used in obesity and other nutrition-related research; Epstein, Dearing, Roba, \& Finkelstein, 2010). In experimental marketplaces, multiple products are available and the experimenter controls the prices for each. These marketplaces can be either physical or virtual stores (similar to online retailers) and permit the examination of demand elasticity and intensity and degree of substitution or complementarity in consumer behavior under conditions that approximate naturalistic settings.

Experiment 2 will extend findings from the first experiment examining the effects of different concentrations of nicotine in cigarettes (0.4mg/g, 1.4mg/g, 2.5mg/g, 5.6mg/g, 17.4mg/g) and blood nictotine absorption on laboratory behavioral economic demand measures. Employing this innovative Experimental Tobacco Marketplace, we propose to examine reduced-nicotine cigarettes under the following conditions: 1) control conditions where lower dose nicotine cigarettes are the only available product in the Experimental Tobacco Marketplace and where the tobacco marketplace is similar to the current real-world marketplace (i.e., no lower dose nicotine cigarettes, but a variety of other tobacco products); 2) lower dose nicotine cigarettes are available with a number of other nicotine products excluding conventional cigarettes; and 3) lower dose nicotine cigarettes are available with a number of other nicotine products including conventional cigarettes.

Study Timeline

• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-28
• Study First Posted: 2016-11-01
• Study Start: 2017-01
• Primary Completion: 2019-11
• Study Completion: 2019-11
• Results First Submitted: 2021-04-22
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-26
• Last Update Submitted: 2021-08-26
• Results First Posted: 2021-09-22
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single arm	SPECTRUM cigarettes	All participants will complete the same experimental events across 6 laboratory sessions.
0.4 mg/g Concentration	SPECTRUM cigarettes between	Participants in this arm will experience the 0.4 mg/g Concentration
1.3 mg/g Concentration	SPECTRUM cigarettes between	Participants in this arm will experience the 1.3 mg/g Concentration
2.4 mg/g Concentration	SPECTRUM cigarettes between	Participants in this arm will experience the 2.4 mg/g Concentration
5.2 mg/g Concentration	SPECTRUM cigarettes between	Participants in this arm will experience the 5.2 mg/g Concentration
15.8 mg/g Concentration	SPECTRUM cigarettes between	Participants in this arm will experience the 15.8 mg/g Concentration

Primary Outcome Measures

Name	Time	Method
Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task	10 minutes after cigarette administration	The Cigarette Purchase Task is a behavioral economic measure of abuse liability that consists of a series of hypothetical questions asking participants to indicate how many cigarettes they would purchase for their own consumption across a range of cigarette prices. Participants smoked one cigarette and then were asked to report how many cigarettes they would smoke within a 24 hour period at the following prices: $0.00 (free), $0.01, $0.05, $0.10, $0.25, $0.50, $1, $2, $5, $10, $25, $50, $100, $200. Nonlinear regression was then used to estimate the number of cigarettes participants would take when they were free using the equation by Koffarnus et al. (2015; doi:10.1037/pha0000045). The outcome is the logarithmically transformed number of cigarettes.
Experimental Marketplace Purchases	Sessions 2-5 with each session conducted one week apart (for 4 weeks total)	In all arms except the single arm, measures of quantities of experimental cigarettes and other nicotine products will be obtained.
Change in Blood Nicotine Content Over the Course of the Session	Each session (6 sessions total) with at least 2 days between each session.	For participants in the single arm only, blood will be collected throughout each session and analyzed for nicotine content. The change in blood nicotine content over the course of the session will be compared among the six sessions where different cigarettes were administered. Blood nicotine (expressed in ng/mL) at minute 0 was subtracted from blood nicotine at minutes 10, 15, 20, 30, 45, and 60 to yield a change in blood nicotine (negative values were truncated to 0) at each of the time points. Using these change in blood nicotine values, we calculated Area Under the Curve (AUC) via the trapezoidal rule, which resulted in a singular number (total change in blood nicotine over the course of each experimental session) in our primary outcome measure.

Trial Locations

Locations (1)

Fralin Biomedical Research Institute at VTC; 🇺🇸 Roanoke, Virginia, United States