Effects of a Specific Substance in Smokers

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281979
• Other study ID #: STUDY00018483
• Secondary ID: K01DA046649
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2023
• Source: Oregon Health and Science University
• Contact: Angelica M Morales, PhD
• Phone: 503-494-4221
• Email: moralean[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impulsivity	Impulsivity will be measured by assessing behavior on a temporal discounting task.	Immediately after beverage/capsule consumption
Primary	Resting State Functional Connectivity	Brain function will be measured while participants are resting using functional magnetic resonance imaging	35 minutes after beverage/capsule consumption
Primary	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
Primary	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