SmokingNCT04281979
Effects of a Specific Substance in Smokers
A study testing Study Agent in people with Smoking, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Study Agent
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Angelica M Morales, PhD, 8186794828, ammorales@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- Study Agent, Placebo
- Keywords
- Nondaily Smoking, Craving, Impulsivity
- Medical subject headings
- Smoking, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study AgentDrug
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).
PlaceboDrug
In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.
| Study group | Role | What they receive |
|---|---|---|
| Study Agent | Experimental | Not described Receives: Drug: Study Agent |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impulsivity
Impulsivity will be measured by assessing behavior on a temporal discounting task.
Measured: Immediately after beverage/capsule consumption
Resting State Functional Connectivity
Brain function will be measured while participants are resting using functional magnetic resonance imaging
Measured: 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
Measured: 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
Measured: 1 year follow-up from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start25 Feb 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Angelica Morales, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281979
- Sponsor's protocol ID
- STUDY00018483
- Other IDs
- K01DA046649
- Status last verified
- Jul 2025
- First submitted
- 7 Feb 2020
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available to users
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An MRI Study of Neural Activity Following Exposure to a Specific Substance in Young Cigarette Smokers
- ClinicalTrials.gov ID
- NCT04281979
- Acronym / sponsor ID
- STUDY00018483
- Conditions
- Smoking
- Keywords
- Nondaily Smoking, Craving, Impulsivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Agent | Experimental | Drug: Study Agent |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study AgentThe 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). | Drug | Study Agent |
| PlaceboIn the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent. | Drug | Placebo |
Primary outcome
Impulsivity
Time frame: Immediately after beverage/capsule consumption
Impulsivity will be measured by assessing behavior on a temporal discounting task.
Resting State Functional Connectivity
Time frame: 35 minutes after beverage/capsule consumption
Brain function will be measured while participants are resting using functional magnetic resonance imaging
Cigarette Craving and Associated Brain Activation
Time frame: 50 minutes after beverage/capsule consumption
Brain function will be measured using functional magnetic resonance imaging while participants complete a Craving Regulation Task
Symptoms of Cigarette Dependence
Time frame: 1 year follow-up from baseline
The Fagerström Test of Nicotine Dependence total score will be used to measure changes in cigarette dependence
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified data will be made available to users
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Agent in people with Smoking, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelica M Morales, PhD (503-494-4221, moralean@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impulsivity (time frame: Immediately after beverage/capsule consumption). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.