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

This study is currently recruiting participants.
Verified March 2017 by Mikhail Koffarnus, Virginia Polytechnic Institute and State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02951143
First Posted: November 1, 2016
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Mikhail Koffarnus, Virginia Polytechnic Institute and State University
  Purpose
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.

Condition Intervention
Substance-Related Disorders Drug: SPECTRUM cigarettes Drug: SPECTRUM cigarettes between

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Mikhail Koffarnus, Virginia Polytechnic Institute and State University:

Primary Outcome Measures:
  • Cigarette Purchase Task [ Time Frame: 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.

  • Change in blood nicotine content [ Time Frame: Prior to and 0, 5, 10, 20, 35, and 50 minutes after cigarette administration ]
    In experiment 1 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.

  • Experimental Marketplace Purchases [ Time Frame: Sessions 2-5 ]
    In experiment 2 only, measures of quantities of experimental cigarettes and other nicotine products will be obtained.


Estimated Enrollment: 232
Actual Study Start Date: January 2017
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm
All participants will complete the same experimental events across 6 laboratory sessions.
Drug: SPECTRUM cigarettes
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 501) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 500) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
Experimental: 0.4 mg/g Concentration
Participants in this arm will experience the 0.4 mg/g Concentration
Drug: SPECTRUM cigarettes between
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.
Experimental: 1.4 mg/g Concentration
Participants in this arm will experience the 1.4 mg/g Concentration
Drug: SPECTRUM cigarettes between
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.
Experimental: 2.5 mg/g Concentration
Participants in this arm will experience the 2.5 mg/g Concentration
Drug: SPECTRUM cigarettes between
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.
Experimental: 5.6 mg/g Concentration
Participants in this arm will experience the 5.6 mg/g Concentration
Drug: SPECTRUM cigarettes between
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.
Experimental: 17.4 mg/g Concentration
Participants in this arm will experience the 17.4 mg/g Concentration
Drug: SPECTRUM cigarettes between
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951143


Contacts
Contact: Brent Kaplan, PhD bkaplan4@vtc.vt.edu

Locations
United States, Virginia
Virginia Tech Carilion Research Institute Recruiting
Roanoke, Virginia, United States, 24016
Contact: Brent Kaplan, PhD         
Principal Investigator: Mikhail N Koffarnus, PhD         
Principal Investigator: Warren K Bickel, PhD         
Sponsors and Collaborators
Virginia Polytechnic Institute and State University
  More Information

Responsible Party: Mikhail Koffarnus, Research Assistant Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT02951143     History of Changes
Other Study ID Numbers: R01DA042535 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2016
First Posted: November 1, 2016
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action