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SexNCT05279053

Mapping Brain Glutamate in Humans: Sex Differences in Cigarette Smokers

An observational study of Sex and Cigarette Smoking, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Sex, Cigarette Smoking
What is being tested?
Abstinence and Smoking
How many people
58 participants
Where
1 siteUnited States
Study dates
1 Apr 2021to 31 Mar 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Target recruitment: 60 adult daily smokers (30 men and 30 women; 18-45 years old), who are otherwise in good health. Interested individuals will be invited to participate in the research project regardless of sex, race or ethnicity, although strong efforts will be made to recruit equal numbers of male and female participants. Individuals will not be excluded from study participation based on race/ethnicity.

Who may be able to join

  • 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
  • Must have smoked for ≥1 year
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  • Must endorse inhaling while smoking
  • Must smoke ≥10 cigarettes per day
  • Must have expired CO >10 ppm and urinary cotinine ≥100 ng/ml at screening/intake
  • Fulfillment of DSM-5 criteria for Tobacco Use Disorder

Who cannot join

  • Seeking treatment for nicotine dependence within 3 months of screening
  • Medical condition that may compromise safety (based on history, physical exam)
  • Neurological disorder that would compromise compliance and/or informed consent
  • Major psychiatric disorder (e.g., Major Depression, Schizophrenia, Bipolar Disorder) per DSM-5 MINI
  • Current drug use disorders other than Tobacco Use Disorder (as defined in DSM-5)
  • Recent use of cocaine, opiates, benzodiazepines, or amphetamines as shown by urine test at the screening or testing sessions
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  • Smoke marijuana >3X/week (self-report) or positive marijuana urine test on a scan day (positive at screening allowed)
  • Use of tobacco in forms other than cigarettes (e.g., snuff, chewing tobacco, e-cigarettes) >10 days in the month before screening
  • Preference for menthol cigarettes, given sex differences in the effect of menthol on the rate of nicotine entry into the brain
  • Pregnancy or nursing
  • Presence in the body of metal that would compromise safety during MRI
  • Claustrophobia
  • Any other condition that would compromise safety

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Semel Institute

    Los Angeles, California, 90095

Other trials in United States

About this study

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.

Read the detailed description

Glutamatergic signaling is dysregulated in addictions, including Tobacco Use Disorder (TUD) , and represents a promising target for smoking cessation therapies. In rodents, NMDA-type glutamate (Glu) receptor antagonists reduce nicotine-seeking behavior, whereas pre-treatment with NMDA-type and AMPA-type Glu receptor antagonists attenuates nicotine self-administration and nicotine-induced dopamine release. In humans, N-acetylcysteine, which regulates Glu via the cysteine-glutamate antiporter and glial Glu transporter, reduces cigarette smoking9 as well as cortical and subcortical levels of Glu itself, measured by magnetic resonance spectroscopy (MRS). These observations suggest that Glu, assayed by MRS, which is a safe and non-invasive in vivo metric, may aid in tracking regional effects of smoking and of anti-smoking interventions.

Notably, evidence has been provided that Glu in the dorsal anterior cingulate cortex (dACC) is associated with smoking-related states, that Glx (the sum of Glu and its primary metabolite, glutamine, Gln) in dACC is higher in smokers than nonsmokers, and that Glx in the insula is higher after overnight abstinence from smoking than during satiety. Further, studies in smokers combining functional magnetic resonance imaging (fMRI) with MRS have linked dACC Glu with activation of the Default Mode Network during cue-induced cigarette craving, and demonstrated reduced dACC Glx and altered dACC-to-DMN connectivity following varenicline treatment. Prior MRS studies of smoking, however, have been limited by single-voxel techniques that sample single brain regions with restricted spatial-resolution and partial volume effects (i.e., including more than one tissue type in the acquisition voxel).

We will exploit the echo-planar spectroscopic imaging (EPSI) variant of MRS in a high-density, anatomically broad assessment of how sex, acute smoking, and ovarian hormones affect brain Glu. Our pilot data indicate that dACC Glu is lower in smoking-abstinent women than men, and lower still in women with higher serum estrogen. After smoking, dACC Glu decreases in men but not in women.

We will use EPSI to determine whether our dACC Glu pilot findings: 1) replicate at high spatial resolution; 2) pertain to the anterior insula and thalamus, which are also implicated in TUD, and 3) on an exploratory basis, pertain to other regions in the rest of the brain. To accomplish this, we will use a recently developed short echo-time (TE=20 ms) variant of 3D EPSI at 3-Tesla. With this state-of-the-art technique, we typically acquire high-quality spectra simultaneously from ~80% of the brain at the very high spatial resolution of ~0.4 cc. Short-TE, moreover, improves segregation of Glu from the overlapping Gln signal.

We teste adult daily smokers (men and women) before and after their first cigarette of the day after ~12 h abstinence. Serum estrogen and progesterone in women were assayed. We addressed two specific aims:

Aim 1: Determine relationships between brain Glu, sex, and circulating ovarian hormones. Hypothesis 1a: Our single-voxel MRS finding that men have higher Glu in the dACC than women after overnight abstinence from smoking will be replicated with EPSI, and will extend to the anterior insula and thalamus. Hypothesis 1b: EPSI will replicate our preliminary finding that Glu in the dACC correlates negatively with serum estrogen (and possibly progesterone) in women, and will show similar relationships of ovarian hormones with the anterior insula and thalamus.

Aim 2: Determine sex differences in acute effects of smoking on brain Glu. Hypothesis 2: The preliminary finding that Glu decreases after acute smoking in the dACC of men but increases or is unchanged in women will be replicated, and will extend to other brain regions.

Ultimately, measurements of sex differences in Glu in specific brain regions, and how Glu changes with smoking and ovarian hormones, can define biomarkers that facilitate development of novel treatments and evaluate therapeutic response in men and women.

Being tested
Abstinence and Smoking
Medical subject headings
Coitus, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abstinence and SmokingBehavioural

    Participants came to the lab after overnight abstinence from smoking and smoked their first cigarette of the day.

Study groups in NCT05279053
Study groupRoleWhat they receive
Male adults who endorse daily smokingParticipants recruited for this study will be male adults (18-45 years old), who smoke cigarettes daily and are generally in good health. They will have no other drug use, other than occasional marijuana or alcohol use, and no major psychiatric disorders. Urine and breath tested metrics will be used to establish whether participants meet drug use-related criteria.
Receives: Behavioral: Abstinence and Smoking
Female adults who endorse daily smokingParticipants recruited for this study will be female adults (18-45 years old), who smoke cigarettes daily and are generally in good health. They will have no other drug use, other than occasional marijuana or alcohol use, and no major psychiatric disorders. Urine and breath tested metrics will be used to establish whether participants meet drug use-related criteria.
Receives: Behavioral: Abstinence and Smoking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glutamate in the Dorsal Anterior Cingulate Cortex

    Glutamate levels, as measured using MRS, in the dorsal anterior cingulate cortex.

    Measured: 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

    Glutamate levels, as measured using MRS, in the insula.

    Measured: 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).

    Glutamate measured using the MRS echoplanar spectroscopic imaging in abstinent smokers.

    Measured: 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

    Estrogen concentration measured in serum from blood samples drawn prior to MRS (women only).

    Measured: Sampling performed on same day as MRS (before smoking).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start1 Apr 2021
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05279053
Sponsor's protocol ID
UCLA IRB 17-000387
Other IDs
5R03DA052719
Status last verified
Mar 2026
First submitted
23 Feb 2022
Last updated
20 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sex and Cigarette Smoking, run by University of California, Los Angeles 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 10 inclusion and 13 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: finished, as of the sponsor's last update on 20 Mar 2026. 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. 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?

Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glutamate in the Dorsal Anterior Cingulate Cortex (time frame: 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.). 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 20 Mar 2026.

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