An interventional study of Study Agent and Placebo in Smoking, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Basic science
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.
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.
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 60 is below the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Study Agent
Drug: Placebo
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).
In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.
Impulsivity
Impulsivity will be measured by assessing behavior on a temporal discounting task.
Time frame: Immediately after beverage/capsule consumption
Resting State Functional Connectivity
Brain function will be measured while participants are resting using functional magnetic resonance imaging
Time frame: 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
Time frame: 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
Time frame: 1 year follow-up from baseline
Plan to share: Yes — De-identified data will be made available to users
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.
No publications or documents are linked to this record.
Started Feb 2020 (actual). Primary completion is estimated for Dec 2025, 70 months after the start.
Of 401 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 70 months is above that.
Counting every sponsor, half of 456 studies reached it within 23 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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