Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT02888249
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
76
1
4
50.5
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Altered composition cigarette
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions
Actual Study Start Date :
Aug 25, 2017
Actual Primary Completion Date :
Nov 10, 2021
Actual Study Completion Date :
Nov 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cigarette W

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

Other: Altered composition cigarette
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.

Experimental: Cigarette X

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

Other: Altered composition cigarette
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.

Experimental: Cigarette Y

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

Other: Altered composition cigarette
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.

Experimental: Cigarette Z

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

Other: Altered composition cigarette
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University School of Medicine, Bayview Campus Baltimore Maryland United States 21224

Sponsors and Collaborators

  • Johns Hopkins University
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Matthew W Johnson, Ph.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02888249
Other Study ID Numbers:
  • IRB00107178
  • 5R01DA042527
First Posted:
Sep 2, 2016
Last Update Posted:
Dec 29, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2021