Clinical trial NCT04281979: Effects of a Specific Substance in Smokers
Official title: An MRI Study of Neural Activity Following Exposure to a Specific Substance in Young Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Keywords: Nondaily Smoking
Craving
Impulsivity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-02-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Impulsivity
timeFrame: Immediately after beverage/capsule consumption
measure: Resting State Functional Connectivity
timeFrame: 35 minutes after beverage/capsule consumption
measure: Cigarette Craving and Associated Brain Activation
timeFrame: 50 minutes after beverage/capsule consumption
measure: Symptoms of Cigarette Dependence
timeFrame: 1 year follow-up from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References: