Behavioral Economic Purchasing Decisions for Cigarettes of Varied Compositions

NCT02888249 | Completed

• 2 other identifiers: IRB001071785R01DA042527
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Substance-Related Disorders

Keywords

Tobacco withdrawal; Autonomic Agents

Outcome Measures

Primary Outcomes (1)

• 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

  3 weeks after initiation of home exposure period

Study Arms (4)

Cigarette W

EXPERIMENTAL

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

Cigarette X

EXPERIMENTAL

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

Cigarette Y

EXPERIMENTAL

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

Cigarette Z

EXPERIMENTAL

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

Interventions

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.

Cigarette W; Cigarette X; Cigarette Y; Cigarette Z

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins University School of Medicine, Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Matthew W Johnson, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 2, 2016
• Study Start: August 25, 2017
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: October 18, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)