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Effects of a Specific Substance in Smokers

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04281979
Enrollment
60
Registered
2020-02-24
Start date
2020-02-25
Completion date
2025-12-31
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

Nondaily Smoking, Craving, Impulsivity

Brief summary

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

DRUGStudy 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).

DRUGPlacebo

In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

In each of the two conditions, participants will be asked to consume a drink and pill. They will be informed that the drink and pill may contain a variety of over the counter substances but they will not be informed about the contents of the drinks and pills until they have completed both the active and placebo visits.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
ImpulsivityImmediately after beverage/capsule consumptionImpulsivity will be measured by assessing behavior on a temporal discounting task.
Resting State Functional Connectivity35 minutes after beverage/capsule consumptionBrain function will be measured while participants are resting using functional magnetic resonance imaging
Cigarette Craving and Associated Brain Activation50 minutes after beverage/capsule consumptionBrain function will be measured using functional magnetic resonance imaging while participants complete a Craving Regulation Task
Symptoms of Cigarette Dependence1 year follow-up from baselineThe Fagerström Test of Nicotine Dependence total score will be used to measure changes in cigarette dependence

Countries

United States

Contacts

Primary ContactAngelica M Morales, PhD
moralean@ohsu.edu503-494-4221

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026