Effects of a Specific Substance in Smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Study Agent, Placebo.
- Who it may be relevant to
- Registry conditions: Smoking. Basic parameters: 21 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An MRI Study of Neural Activity Following Exposure to a Specific Substance in Young Cigarette Smokers
Overview
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
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.
Interventions
- Drug Study Agent
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). - Drug Placebo
In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.
Primary outcome measures
- Impulsivity [Time frame: Immediately after beverage/capsule consumption]
- Resting State Functional Connectivity [Time frame: 35 minutes after beverage/capsule consumption]
- Cigarette Craving and Associated Brain Activation [Time frame: 50 minutes after beverage/capsule consumption]
- Symptoms of Cigarette Dependence [Time frame: 1 year follow-up from baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Oregon Health and Science University — Portland
Identifiers
NCT: NCT04281979 · STUDY00018483 · K01DA046649