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Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions

Primary Purpose

Tobacco Use Disorder, Substance-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Altered composition cigarette
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder focused on measuring Tobacco withdrawal, Autonomic Agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Johns Hopkins University School of Medicine, Bayview Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cigarette W

Cigarette X

Cigarette Y

Cigarette Z

Arm Description

Altered composition cigarettes moisture = 12.20 %, tar = 10.40 mg/cigarette, total particulate matter = 12.0 mg/cigarette, high sugar content

Altered composition cigarettes moisture = 12.10 %, tar = 8.60 mg/cigarette, total particulate matter = 9.60 mg/cigarette, low sugar content

Altered composition cigarettes moisture = 13.20 %, tar = 9.10 mg/cigarette, total particulate matter = 10.10 mg/cigarette, low sugar content

Altered composition cigarettes moisture = 13.60 %, tar = 8.10 mg/cigarette, total particulate matter = 9.10 mg/cigarette, low sugar content

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 23, 2016
Last Updated
October 17, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02888249
Brief Title
Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
Official Title
Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Substance-Related Disorders
Keywords
Tobacco withdrawal, Autonomic Agents

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cigarette W
Arm Type
Experimental
Arm Description
Altered composition cigarettes moisture = 12.20 %, tar = 10.40 mg/cigarette, total particulate matter = 12.0 mg/cigarette, high sugar content
Arm Title
Cigarette X
Arm Type
Experimental
Arm Description
Altered composition cigarettes moisture = 12.10 %, tar = 8.60 mg/cigarette, total particulate matter = 9.60 mg/cigarette, low sugar content
Arm Title
Cigarette Y
Arm Type
Experimental
Arm Description
Altered composition cigarettes moisture = 13.20 %, tar = 9.10 mg/cigarette, total particulate matter = 10.10 mg/cigarette, low sugar content
Arm Title
Cigarette Z
Arm Type
Experimental
Arm Description
Altered composition cigarettes moisture = 13.60 %, tar = 8.10 mg/cigarette, total particulate matter = 9.10 mg/cigarette, low sugar content
Intervention Type
Other
Intervention Name(s)
Altered composition cigarette
Intervention Description
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 Outcome Measure Information:
Title
Demand Intensity: Number of cigarette puffs obtained at the lowest fixed ratio value
Description
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
Time Frame
3 weeks after initiation of home exposure period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew W Johnson, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine, Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions

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