Effects of a Specific Substance in Smokers

NCT04281979 | Recruiting DMC

• 2 other identifiers: STUDY00018483K01DA046649
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Nondaily Smoking; Craving; Impulsivity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Study Agent

EXPERIMENTAL

Drug: Study Agent

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Study Agent 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).

Study Agent

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Impulsive Behavior

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Angelica M Morales, PhD

CONTACT

503-494-4221; moralean@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 24, 2020
• Study Start: February 25, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: After data are published
• 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.

Locations

US (1)