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OpenTrials
Completed

NCT Number: NCT02888249

Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions

The purpose of this study is to determine whether the abuse liability of cigarettes with altered composition (cigarettes differing in composition; e.g., tar levels, amount of sugar, casings) is reduced relative to standard composition cigarettes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine, Bayview Campus

Baltimore, Maryland, 21224, United States

About this study

The proposed study will determine the abuse liability of altered composition cigarettes compared to standard cigarettes using a behavioral economics abuse-liability approach. Behavioral economic demand analysis constitutes a comprehensive examination of drug reinforcement and abuse liability. Laboratory determination of cigarette consumption under various response requirements will occur before and after 3 weeks of at-home exposure, with participants randomized to cigarettes varying in composition to determine the role of experience on the abuse-liability of various cigarettes. Abuse liability will be assessed by 2 essential demand metrics: lower demand intensity and increased demand elasticity, as well as other demand metrics and subjective ratings of "liking". The study will also determine the degree to which altered composition cigarettes may substitute for standard composition cigarettes - testing whether an altered composition policy would achieve the goal of reducing standard cigarette consumption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Smoke at least five cigarettes per day
  • Have an expired carbon monoxide level of more than 8 ppm or a urinary cotinine level of more than 100 ng per milliliter
  • Have a Fagerström Test for Nicotine Dependence score of at least 5 upon screening

Exclusion criteria

  • The intention to quit smoking in the next 30 days
  • The use of other tobacco products in addition to machine-manufactured cigarettes on more than 9 of the previous 30 days
  • Use of "roll your own" cigarettes as an exclusive form of smoking
  • A serious medical or psychiatric disorder or unstable condition
  • Any positive toxicological screening for illicit drugs other than cannabis will be excluded
  • Women who are pregnant, plan to become pregnant or are breast-feeding

Treatment and study plan

Altered composition cigarette

Other

This double-blind study will systematically determine the abuse liability of altered composition cigarettes using a behavioral economics abuse-liability approach. Altered composition cigarettes (e.g., cigarettes differing in casings, sugars, tar levels, moisture) may result in decreased intake and decreased dependence, although critical questions remain regarding the abuse-liability of altered composition cigarettes, whether exposure to these cigarettes reduces use, and whether altered composition cigarettes will substitute for standard cigarettes. The addictive effects and abuse liability of altered composition cigarettes, therefore, are not well understood, and will be tested in this study.

Primary outcomes

  1. Demand Intensity: Number of cigarette puffs obtained at the lowest fixed ratio value

    Time frame: 3 weeks after initiation of home exposure period

    The primary behavioral economic demand curve metric (demand intensity, i.e., number of cigarette puffs obtained at the lowest fixed ratio value assessed) derived from cigarette consumption in the laboratory

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2016
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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