Riboflavin for Glutamate Reduction in Alcohol Withdrawal
NCT ID: NCT04232800
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2021-12-01
2022-10-25
Brief Summary
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Detailed Description
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Hypotheses:
1. Aim 1: Measure the impact of daily oral riboflavin supplementation on blood Glu levels.
Hypothesis 1: Patients receiving riboflavin will have significant reductions in blood Glu levels, as compared to placebo.
2. Aim 2: Observe the impact of oral riboflavin on CIWA-AR scale scoring. Hypothesis 2: Riboflavin will significantly reduce the active group's CIWA-AR scores, and will result in fewer symptom triggered benzodiazepine doses, as compared to placebo.
Plan: The proposed study would apply a recently identified method using vitamin B2 (riboflavin) to reduce excess brain Glu activity in veterans in acute alcohol withdrawal. This method of "glutamate scavenging", was identified in a 2018 as a way to reduce glutamate associated brain damage which typically occurs after stroke. When tested in human patients immediately following stroke, the intervention demonstrated efficacy through better structural and functional outcomes when compared to placebo. Improvements persisted at 3 months after the initial stroke, and were not associated with any known side effects. Administration of riboflavin quickly decreases Glu levels in both the blood and brain, as measured using chromatography and Magnetic Resonance Imaging (MRI), respectively. As riboflavin's Glu reducing properties have just been discovered, this method has only been applied to the treatment of stroke, and has yet to be studied outside of the field of neurology. Further, oral riboflavin has not been investigated as a method of glutamate reduction. The hyperglutamatergic state in patients with alcohol withdrawal provides one opportunity for such an investigation, one that may lead to future studies improving treatments of alcohol withdrawal. Chronic, as well as acute alcohol users have both elevated extracellular glutamate as well as changes to glutamate receptors and transporters. These changes appear play a role in the rewarding effects of alcohol, and contribute to the symptoms of withdrawal. A positive correlation exists between CSF levels of glutamate and the severity of alcohol dependence, and patients in acute withdrawal have measurably increased levels of glutamate in their peripheral blood. During early withdrawal, elevated glutamate levels have been observed in the hippocampus and anterior cingulate cortex, returning to normal 3 days after symptom resolution. Given this information, riboflavin may provide a safe, effective, and affordable intervention to normalize the hyperglutamatergic state associated with alcohol withdrawal. The proposed study would investigate this hypothesis in patients admitted to the inpatient psychiatry unit in acute alcohol withdrawal.
Methods: Participants would be recruited on the inpatient psychiatry unit as they were admitted. The primary teams/on call residents would be asked to page a study member if a patient was admitted on the standard protocol for alcohol withdrawal: the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar). The study coordinator would consent the patient, and they would be randomized to either the placebo or riboflavin group. They would then receive TID oral dosing of either 100mg riboflavin or placebo, in addition to treatment as usual. The primary outcome would be daily blood glutamate levels, obtained with the normal morning labs. Secondary outcomes would CIWA scores, number of symptom-triggered benzodiazepines given, anxiety, and alcohol craving scores (using standardized measures).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Riboflavin
Participants in this group will receive 100mg riboflavin TID during study participation.
Riboflavin
The intervention will consist of 100mg riboflavin (vitamin B2) given in three time daily dosing.
Placebo
Participants in this group will receive inert placebo capsules TID during study participation.
Placebo
An inert, standard placebo in identical capsules to primary intervention.
Interventions
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Riboflavin
The intervention will consist of 100mg riboflavin (vitamin B2) given in three time daily dosing.
Placebo
An inert, standard placebo in identical capsules to primary intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to the inpatient psychiatric unit at the Portland VA
* Determine by admitting physician to be currently in or at risk of alcohol withdrawal during admission
* Placed on the CIWA-AR protocol
* Willing to provide informed consent/HIPAA authorization and accept randomization
* Willing to ingest three capsules/day
* Willing to provide daily blood samples H) Fluent in English
Exclusion Criteria
* Taking any medication acting primarily on Glu receptors (e.g. memantine) or GABA receptors (benzodiazepines) at baseline
* Unable to swallow capsules
* Actively in withdrawal from substances other than alcohol
* Unable to provide full informed consent/HIPAA authorization
18 Years
65 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Responsible Party
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Andrew Hughes
Principal Investigator
Principal Investigators
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Brandon Cornejo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health & Science University, Portland Veterans Health Administration
Central Contacts
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Other Identifiers
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RGRAW
Identifier Type: -
Identifier Source: org_study_id
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