Effects of a Specific Substance in Smokers

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

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Drug: Study Agent; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.
EXPERIMENTAL: Study Agent	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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 25, 2020
• Primary Completion (ANTICIPATED): March 31, 2024
• Study Completion (ANTICIPATED): March 31, 2024

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Impulsivity; Craving; Nondaily Smoking
• Other Study ID Numbers: STUDY00018483; K01DA046649 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made available to users
• IPD Sharing Time Frame: After data are published
• IPD Sharing Access Criteria: Data Use Agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to deleting the data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No