Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT04281979

Conditions

Smoking

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Study Agent

Placebo

Study Details

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.

Conditions

Smoking

Study ID

NCT04281979

Start date

Feb 25, 2020

Status verified date

Jul, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Study Agent

placebo comparator: Placebo

Interventions

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).

Placebo

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Angelica M Morales, PhD

503-494-4221moralean@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Angelica M Morales, PhD

8186794828ammorales@gmail.com

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jul 28, 2025

Last verified

Jul, 2025

Keywords

  • Nondaily Smoking
  • Craving
  • Impulsivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-07-28.