Mapping Brain Glutamate in Humans: Sex Differences in Cigarette Smokers (NCT05279053) | Clinical Trial Compass
CompletedNot Applicable
Mapping Brain Glutamate in Humans: Sex Differences in Cigarette Smokers
United States58 participantsStarted 2021-04-01
Plain-language summary
The proposed study evaluated sex differences in glutamate (Glu), with a focus on the dorsal anterior cingulate cortex (dACC), anterior insula, and thalamus, as well as how it is influenced by sex (males vs. females), smoking state (overnight abstinent vs. sated), and circulating ovarian hormones (estrogen and progesterone) in women. Glu was measured in the entire brain with special focus on the dorsal anterior cingulate cortex (dACC), anterior insula, and thalamus, all of which have been implicated in tobacco withdrawal, using an echo-planar spectroscopic imaging (EPSI) variant of magnetic resonance spectroscopy (MRS). Serum ovarian hormones (estrogen and progesterone) were measured for female participants to determine relationships between brain Glu and this hormone. Glu was be measured in smokers after overnight (\~12 h) abstinence and after participants smoked the first cigarette of the day.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Self-identified as only male or female
. Age 18-45 years (children \<18 years will be excluded due to low prevalence of conventional cigarette smoking; female participants \>45 years of age will be excluded to avoid effects of perimenopause and menopause in women; male participants \>45 years of age will be excluded as well to ensure that male and female groups are matched on age
. English fluency demonstrated by verbal skills sufficient to participate in a conversation, including the ability to ask and answer questions at a level that assures adequate understanding of the study (a comprehension quiz will be given)
. Right handedness (evaluated using the Edinburgh Inventory)
. Generally in good health without cardiovascular, hepatic, renal, or autoimmune diseases, diabetes, or cancer
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glutamate in the Dorsal Anterior Cingulate Cortex
Timeframe: Measured before and after smoking a cigarette by both groups (men and women). Group means below reflect overall group means averaged across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.
2
Glutamate in the Insula
Timeframe: Measured before and after smoking a cigarette by both groups (men and women). Group means below reflect overall group means averaged across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.
3
Glutamate in Whole Brain (Gray Matter Plus White Matter).
Timeframe: Measured before and after smoking a cigarette by both groups (men and women). Group means below reflect overall group means averaged across time points as reported from descriptive statistics in the Generalized Linear Mixed Model.
4
Serum Estrogen
Timeframe: Sampling performed on same day as MRS (before smoking).