Effects of a Specific Substance in Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-25

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

In each of the two conditions, participants will be asked to consume a drink and pill. They will be informed that the drink and pill may contain a variety of over the counter substances but they will not be informed about the contents of the drinks and pills until they have completed both the active and placebo visits.

Study Groups

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Study Agent

Group Type EXPERIMENTAL

Study Agent

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes