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

NCT02951143 | Completed Results

• 1 other identifier: R01DA042535
• Study Type: interventional
• Target: 305
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (3)

• Estimated Cigarettes Taken at Free Price Derived From the Cigarette Purchase Task

  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.

  10 minutes after cigarette administration

• Change in Blood Nicotine Content Over the Course of the 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.

  Each session (6 sessions total) with at least 2 days between each session.

• Experimental Marketplace Purchases

  In all arms except the single arm, measures of quantities of experimental cigarettes and other nicotine products will be obtained.

  Sessions 2-5 with each session conducted one week apart (for 4 weeks total)

Study Arms (6)

Single arm

EXPERIMENTAL

All participants will complete the same experimental events across 6 laboratory sessions.

Drug: SPECTRUM cigarettes

0.4 mg/g Concentration

EXPERIMENTAL

Participants in this arm will experience the 0.4 mg/g Concentration

Drug: SPECTRUM cigarettes between

1.3 mg/g Concentration

EXPERIMENTAL

Participants in this arm will experience the 1.3 mg/g Concentration

Drug: SPECTRUM cigarettes between

2.4 mg/g Concentration

EXPERIMENTAL

Participants in this arm will experience the 2.4 mg/g Concentration

Drug: SPECTRUM cigarettes between

5.2 mg/g Concentration

EXPERIMENTAL

Participants in this arm will experience the 5.2 mg/g Concentration

Drug: SPECTRUM cigarettes between

15.8 mg/g Concentration

EXPERIMENTAL

Participants in this arm will experience the 15.8 mg/g Concentration

Drug: SPECTRUM cigarettes between

Interventions

SPECTRUM cigarettes DRUG

Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.

Single arm

SPECTRUM cigarettes between DRUG

Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.

0.4 mg/g Concentration; 1.3 mg/g Concentration; 15.8 mg/g Concentration; 2.4 mg/g Concentration; 5.2 mg/g Concentration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• University of Kentucky: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Mikhail Koffarnus
• Organization: University of Kentucky

koffarnus@uky.edu

8593236402

Study Officials

• Warren K Bickel, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 1, 2016
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 22, 2021
• Results First Posted: September 22, 2021

Record last verified: 2021-08

Locations

US (1)