Effects of a Specific Substance in Smokers

Study Overview
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Brief Summary
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Although rates of cigarette use are declining, the proportion of nondaily smokers is rising, particularly among young adults. Among young adults, nondaily smoking is associated with negative health consequences and, for some, may lead to the establishment of life-long smoking patterns. The goal of this project is to understand the behavioral, psychological and neurobiological factors that contribute to cigarette use in nondaily smokers to aid the development of tailored evidence-based interventions.

Detailed Description
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The purpose of this study is to investigate the neurobiological mechanisms associated with cigarette use in young nondaily smokers (ages 21-25). Nondaily smokers experience fewer symptoms of cigarette withdrawal than daily smokers; however, they still experience difficulty quitting. Since smoking cessation before the age of 30 substantially attenuates the long-term health consequences associated with smoking, understanding the factors that motivate cigarette use in young nondaily smokers and developing tailored interventions will be critical for curbing cigarette use and improving public health. The proposed project will use functional magnetic resonance imaging (fMRI) to examine how other substances (e.g. stimulates, sedatives, or analgesics) impact brain function and will assess the extent to which substance-induced changes in brain function correlate with impulsive choice, cigarette craving, and craving regulation in young adults. Furthermore, the investigators will assess how substance-induced changes in brain function, impulsivity, craving, and capacity for craving regulation predict cigarette use over the course of 1 year.

Official Title
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An MRI Study of Neural Activity Following Exposure to a Specific Substance in Young Cigarette Smokers

Conditions
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Smoking

Intervention / Treatment
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* Drug: Study Agent
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 21-40 years old Right-handed Fluent in English Report smoking cigarettes or e-cigarettes 1-27 days in the past month Report binge drinking based on NIAAA criteria (5 or more drinks per occasion for males, 4 or more drinks per occasion for females) at least 1 time in the past 90 days without adverse incident Exclusion Criteria: Seeking treatment for substance use (e.g. nicotine or alcohol use) Moderate or Severe Nicotine Dependence Current alcohol use disorder Illicit substance use other than marijuana use in the past year Marijuana use more than 10 times in the past year Major neurological or medical illness - Significant head trauma - Current use of medication affecting the central nervous system MRI contraindications (e.g. irremovable metal on the body or pregnancy)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study will examine the acute effects of a substance (e.g. stimulant, sedative, analgesic) on a single group of nondaily smokers. All participants will complete 2 experimental sessions under the influence of a substance or placebo. The order of the active and placebo sessions will be randomized.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Agent<br> | Drug: Study Agent<br>* The study agent will be administered via beverages and/or a capsule. The substances used in the study are legal, non-prescription, and are proven safe for human consumption at the doses used. The study agent may be a depressant (such as alcohol), a stimulant (such as caffeine), or an analgesic (such as aspirin).<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impulsivity | Impulsivity will be measured by assessing behavior on a temporal discounting task. | Immediately after beverage/capsule consumption | 
| Resting State Functional Connectivity | Brain function will be measured while participants are resting using functional magnetic resonance imaging | 35 minutes after beverage/capsule consumption | 
| Cigarette Craving and Associated Brain Activation | Brain function will be measured using functional magnetic resonance imaging while participants complete a Craving Regulation Task | 50 minutes after beverage/capsule consumption | 
| Symptoms of Cigarette Dependence | The Fagerström Test of Nicotine Dependence total score will be used to measure changes in cigarette dependence | 1 year follow-up from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nondaily Smoking, Craving, Impulsivity