Substance-Related Disorders, Tobacco Use Disorder
Conditions
Keywords
Tobacco withdrawal, Autonomic Agents
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.
Interventions
OTHERAltered 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed