Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 4 of 530 for:    Open Studies | "Substance-Related Disorders"

Abuse Liability of Reduced Nicotine Content Cigarettes Within a Complex Tobacco Marketplace: Experiment 1

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by Virginia Polytechnic Institute and State University
Sponsor:
Information provided by (Responsible Party):
Mikhail Koffarnus, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT02951143
First received: October 27, 2016
Last updated: October 28, 2016
Last verified: October 2016
  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 and how this is related to nicotine content and absorption. 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

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

Primary Outcome Measures:
  • Cigarette Purchase Task [ Time Frame: 10 minutes after cigarette administration ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 58
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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 or lactating
  • have plans to move out of the area during the course of the experiment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02951143

Contacts
Contact: Mikhail N Koffarnus, PhD 540-526-2107 mickyk@vtc.vt.edu

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 
Study First Received: October 27, 2016
Last Updated: October 28, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 09, 2016