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Imaging Techniques for Alcoholism

RN
Overseen ByRajesh Narendran
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Rajesh Narendran
Must not be taking: Psychotropics, Metformin, Insulin, NSAIDs
Disqualifiers: Schizophrenia, Bipolar, Opioids, Diabetes, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brains of people with alcohol use disorder (AUD) function, focusing on energy use and specific brain processes. Participants will undergo specialized brain scans using treatments like [F-18]BCPP-EF (a radiotracer used in PET scans) and [F-18]FDG (a glucose-based radiotracer) to assess these functions. The trial seeks individuals with a recent pattern of heavy drinking who meet specific criteria for AUD, excluding those with other major mental health or substance issues. Those who meet these criteria may be suitable for the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

What prior data suggests that these imaging techniques are safe for studying alcoholism?

In previous studies, researchers have used [F-18]BCPP-EF as a PET scan tool to study brain activity. Research shows it is generally well-tolerated, with no serious side effects reported, making it a promising option for examining brain functions.

Similarly, [F-18]FDG has been widely used to study how the brain uses energy. It is considered safe and well-tolerated for this purpose. This compound is commonly used in PET scans to observe how the brain processes glucose, its main energy source.

Both [F-18]BCPP-EF and [F-18]FDG serve as imaging tools and are not treatments for any disease. They help researchers understand brain function in different situations without causing harm.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses innovative imaging techniques to better understand alcoholism. Unlike most current methods that focus on behavioral and pharmaceutical treatments, this trial employs [F-18]BCPP-EF and [F-18]FDG in Positron Emission Tomography (PET) scans to explore brain activity. These scans can provide detailed insights into the brain's metabolic processes, potentially revealing new targets for treatment. By visualizing how alcoholism affects the brain, researchers hope to develop more effective therapies and improve recovery outcomes.

What evidence suggests that these imaging techniques are effective for studying alcoholism?

Research has shown that [F-18]BCPP-EF, which participants in this trial may receive, is a promising tool for imaging brain activity related to mitochondrial function. It reveals how well different brain regions are functioning, which could be crucial for understanding changes in the brain due to alcohol use disorder (AUD).

For [F-18]FDG, another imaging option in this trial, studies have demonstrated its ability to track brain metabolism. It measures how the brain uses glucose, which often changes in individuals with AUD. These imaging techniques could help scientists gain a better understanding of brain changes in people with alcohol use issues.16789

Who Is on the Research Team?

RN

Rajesh Narendran, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults with alcohol use disorder (problem drinking or alcoholism) as well as healthy individuals to serve as a comparison group. Participants must be able to safely undergo brain imaging scans.

Inclusion Criteria

Healthy controls (HC): No history of heavy drinking as defined using NIAAA criteria in the past year
Alcohol use disorders (AUD): Fulfill DSM-5 criteria for alcohol use disorder
Alcohol use disorders (AUD): History of NIAAA heavy drinking in the past 30 days (males: >4 drinks any day or >14 drinks per week; females: >3 drinks any day or >7 drinks per week)
See 3 more

Exclusion Criteria

I have not worked with radiation or joined radiation studies in the past year above safe limits.
Alcohol use disorders (AUD): No other major DSM-5 psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, developmental disorders, or current depressive disorders unless related to alcohol intoxication, withdrawal, or alcohol-induced mood disorder
Alcohol use disorders (AUD): No other DSM-5 substance use disorders including opioids, cocaine, amphetamines, sedative-hypnotics, hallucinogens, inhalants; moderate and severe DSM-5 cannabis and tobacco use disorder excluded
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo baseline PET scans to image mitochondrial complex I and cerebral glucose metabolism

1 day
1 visit (in-person)

Follow-up

Participants are monitored for relapse to alcohol and other measures over an 8-week period

8 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • [F-18]BCPP-EF
  • [F-18]FDG

Trial Overview

The study uses special PET scans with two tracers, [F-18]BCPP-EF and [F-18]FDG, to look at how the brain's energy systems work in people with alcohol use disorder compared to healthy controls.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: PETExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rajesh Narendran

Lead Sponsor

Trials
4
Recruited
180+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6128779/

Imaging resilience and recovery in alcohol dependence - PMC

This paper describes how imaging studies in man can be used to assess the neurobiological correlates of resilience and, if longitudinal, of disease ...

2.

radiology.ucsf.edu

radiology.ucsf.edu/people/dieter-meyerhoff/publications

Dieter Meyerhoff, PhD's Publications

Multi-modal neuroimaging reveals differences in alcohol-cue reactivity but not neurometabolite concentrations in adolescents who drink alcohol. Combined ...

3.

researchgate.net

researchgate.net/publication/393007481_18FBCPP-BF-PET_as_an_imaging_tool_for_mitochondrial_dysfunction_in_diabetic_pancreatopathy_and_nephrotoxicity

18F]BCPP-BF-PET as an imaging tool for mitochondrial ...

Results: Isoflurane did not affect MC-I activity measured in terms of (18)F-BCPP-EF uptake in living brain. ... (18)F-BCPP-EF, (18)F-BCPP ...

4.

researchgate.net

researchgate.net/publication/334584169_Characterization_of_3_PET_tracers_for_quantification_of_mitochondrial_and_synaptic_function_in_healthy_human_brain_18F-BCPP-EF_11C-SA-4503_and_11C-UCB-J

18F-BCPP-EF, 11C-SA-4503, and 11C-UCB-J | Request PDF

The present study demonstrated that (18)F-BCPP-EF may be a potential PET probe for quantitative imaging MC-1 activity in the living brain using ...

5.

withpower.com

withpower.com/trial/18fnos-imaging-for-alcoholism-68d5c

[18F]NOS Imaging for Alcoholism (AUD Trial)

This trial explores the connection between inflammation in the brain and body and alcohol use disorder (AUD) using a PET/CT scan with the radiotracer [18F]NOS.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3624044/

Polysubstance and Alcohol Dependence - PMC - NIH

Alcohol use disorders (AUD) are often accompanied by comorbid misuse of illicit drugs, such as cocaine and methamphetamine (Stinson et al., 2005) ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28125711/

Monitoring Mitochondrial Complex-I Activity Using Novel ...

The results suggest that 18F-BCPP-EF is a promising "positive" MC-I imaging PET probe for early detection of efficacy of tumor radiotherapy.

8.

trialticker.com

trialticker.com/clinical-trials/NCT07773649/imaging-mitochondrial-complex-i-in-cocaine-use-disorder-a-f-18-bcpp-ef-pet-study

Imaging Mitochondrial Complex-I in Cocaine Use Disorder

a [F-18]BCPP-EF PET Study. This study uses [18F]BCPP-EF CUD) alcohol, opioids, sedative-hypnotics, hallucinogens, and inhalant use disorders in ...

9.

omicsonline.org

omicsonline.org/open-access/mitochondrial-complex-i-deficit-in-the-olfactory-systems-of-agerelated-neurodegenerative-monkey-models-a-pet-study-using-18fbcppef-2161-0460-1000433-100939.html

Journal of Alzheimers Disease & Parkinsonism

In the present study, the applicability of 18F-BCPP-EF to predict age-related neurodegenerative damage in the monkey brain as an MC-I deficit in the OBA was ...

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