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NCT Number: NCT04281979

Effects of a Specific Substance in Smokers

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.

Recruiting

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Key information

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Angelica M Morales, PhD

CONTACT

[email protected]

8186794828

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Study Agent

Drug

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).

Placebo

Drug

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

Primary outcomes

  1. Impulsivity

    Time frame: Immediately after beverage/capsule consumption

    Impulsivity will be measured by assessing behavior on a temporal discounting task.

  2. Resting State Functional Connectivity

    Time frame: 35 minutes after beverage/capsule consumption

    Brain function will be measured while participants are resting using functional magnetic resonance imaging

  3. Cigarette Craving and Associated Brain Activation

    Time frame: 50 minutes after beverage/capsule consumption

    Brain function will be measured using functional magnetic resonance imaging while participants complete a Craving Regulation Task

  4. Symptoms of Cigarette Dependence

    Time frame: 1 year follow-up from baseline

    The Fagerström Test of Nicotine Dependence total score will be used to measure changes in cigarette dependence

Study contacts

Contact information is provided by the study sponsor or research team.

Angelica M Morales, PhD

CONTACT

[email protected]

503-494-4221

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2020
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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