30 Participants Needed

PET Imaging for Alcoholism

TN
RB
Overseen ByRobert B Innis, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Mental Health (NIMH)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants must not have taken antidepressants or antipsychotic medications in the week before or during their hospital stay. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is PET imaging for alcoholism safe for humans?

PET imaging, which uses radiotracers to study brain function, has been used extensively in humans and is generally considered safe. The radiotracers used in PET scans are in very low concentrations and do not significantly affect the body's systems.12345

How does PET imaging differ from other treatments for alcoholism?

PET imaging is unique because it uses a special type of scan to study the brain's activity and metabolism, helping to understand how alcohol affects the brain and to track changes during treatment. Unlike traditional treatments that focus on medication or therapy, PET imaging provides detailed insights into the brain's function, which can guide more personalized treatment strategies.14567

What is the purpose of this trial?

Background:People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain. Researchers want to find out if people with AUD also have low levels of PDE4B. This research may help lead to better treatments for AUD.Objective:To find out (1) if PDE4B levels are lower in people who are withdrawing from AUD and (2) if their PDE4B levels go up after they abstain from alcohol for 3 to 4 weeks.Eligibility:Adults aged 18 to 70 years with AUD. They must be enrolled in protocol 14-AA-0181.Design:Participants enrolled in protocol 14-AA-0181 will stay in the clinic for 3 to 4 weeks for alcohol withdrawal. During this stay, they will have some added procedures for the current study.Within the first week, participants will have a positron emission tomography (PET) scan of the brain. A needle will be used to guide a thin plastic tube (catheter) into a vein in one arm. An experimental substance called a radioactive tracer will be injected through the catheter. This tracer binds to PDE4B and makes it easier to see the protein in the brain. For the scan, participants will lie on a table that slides into a doughnut-shaped machine.Participants will have a second PET scan toward the end of their stay in the clinic.Participants may also have a magnetic resonance imaging (MRI) scan of the brain. They will lie on a bed that slides into a tube.

Research Team

RB

Robert B Innis, M.D.

Principal Investigator

National Institute of Mental Health (NIMH)

Eligibility Criteria

This trial is for adults aged 18 to 70 with Alcohol Use Disorder (AUD) who are already enrolled in protocol 14-AA-0181. They will undergo alcohol withdrawal in a clinic for about a month and participate in additional procedures to measure PDE4B levels.

Inclusion Criteria

Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document
Willingness to complete the study including MRI tests
Participants must have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists
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Exclusion Criteria

Clinically significant abnormalities on laboratory testing beyond that expected in participants during alcohol withdrawal. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)
I cannot lie flat or still for two hours due to physical or psychological reasons.
Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Alcohol Withdrawal and Initial PET Scan

Participants undergo alcohol withdrawal and have an initial PET scan within the first week of admission

1 week
1 visit (in-patient)

Continued Alcohol Withdrawal and Second PET Scan

Participants continue alcohol withdrawal and have a second PET scan after 3-4 weeks

3-4 weeks
1 visit (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • 18F-PF-06445974
Trial Overview The study tests if the protein PDE4B is at lower levels during AUD withdrawal and if it increases after abstaining from alcohol. Participants will have PET scans using an experimental tracer, 18F-PF-06445974, to visualize PDE4B, possibly along with MRI scans.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: One-armExperimental Treatment1 Intervention
All subjects will receive the same tests.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Mental Health (NIMH)

Lead Sponsor

Trials
3,007
Recruited
2,852,000+

Findings from Research

Positron emission tomography (PET) studies have revealed that alcohol's rewarding effects are linked to changes in various neurotransmitter systems, including dopamine and GABA, as well as its caloric properties, which contribute to alcohol use disorders (AUD).
Research has shown that chronic alcohol exposure leads to significant alterations in brain metabolism and neurotransmitter function, which are associated with compulsive drinking and withdrawal symptoms, highlighting the potential for PET imaging to inform treatment strategies for AUD.
Neurochemical and metabolic effects of acute and chronic alcohol in the human brain: Studies with positron emission tomography.Volkow, ND., Wiers, CE., Shokri-Kojori, E., et al.[2018]
In a study of 30 non-treatment-seeking alcoholics, aripiprazole (15 mg for 14 days) significantly reduced heavy drinking compared to a placebo, indicating its potential efficacy in promoting abstinence.
Brain imaging results showed that aripiprazole blunted activation in the right ventral striatum in response to alcohol cues, suggesting that it may alter the brain's response to alcohol-related stimuli.
The effect of aripiprazole on cue-induced brain activation and drinking parameters in alcoholics.Myrick, H., Li, X., Randall, PK., et al.[2022]
Molecular imaging techniques like PET and SPECT have revealed that alcohol use disorder (AUD) is associated with significant changes in brain metabolism and neuroinflammation, particularly highlighting the role of GABA A-type receptors and the microglial marker translocator protein (TSPO).
Studies indicate that AUD patients show impaired dopamine synthesis and release, which may contribute to the disorder, while opioid receptor antagonists may help mitigate neuroinflammation, suggesting potential avenues for treatment development.
Molecular Imaging Studies of Alcohol Use Disorder.Bach, P., de Timary, P., Gründer, G., et al.[2023]

References

Neurochemical and metabolic effects of acute and chronic alcohol in the human brain: Studies with positron emission tomography. [2018]
The effect of aripiprazole on cue-induced brain activation and drinking parameters in alcoholics. [2022]
Molecular Imaging Studies of Alcohol Use Disorder. [2023]
Brain 18FDG-PET pattern in patients with alcohol-related cognitive impairment. [2021]
Positron emission tomography as a tool for studying alcohol abuse. [2021]
Changes in cerebral [18F]-FDG uptake induced by acute alcohol administration in a rat model of alcoholism. [2018]
Monitoring the Brain's Response to Alcohol With Positron Emission Tomography. [2020]
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