Riboflavin for Glutamate Reduction in Alcohol Withdrawal

NCT04232800 | Unknown Phase 2

• 1 other identifier: RGRAW
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This RCT intends to investigate the use of oral Riboflavin (Vitamin B2) for reduction of blood glutamate levels in the setting of acute alcohol withdrawal. Participants will be patients admitted to an inpatient hospital unit diagnosed with acute alcohol withdrawal. In addition to receiving care as usual, they will be randomized to receive either 100mg TID riboflavin or an identically dosed placebo. The primary outcome measure will be blood glutamate levels. Secondary outcomes will include measures of alcohol withdrawal and alcohol craving. The investigators hypothesize that those in the riboflavin group will have lower blood levels of glutamate, as well as decreased symptoms of alcohol withdrawal.

Conditions

Alcohol Withdrawal; Nutrition Disorders; Alcohol Use Disorder

Keywords

Glutamate; Riboflavin

Outcome Measures

Primary Outcomes (6)

• Peripheral blood glutamate level at baseline

  measured using high performance liquid chromatography (HPLC)

  Will occur on the day of enrollment in the study

• Peripheral blood glutamate level, day 2

  measured using high performance liquid chromatography (HPLC)

  Will occur on day 2 of the study

• Peripheral blood glutamate level, day 4

  measured using high performance liquid chromatography (HPLC)

  Will occur on day 4 of the study

• Peripheral blood glutamate level, day 6

  measured using high performance liquid chromatography (HPLC)

  Will occur on day 6 of the study

• Peripheral blood glutamate level, day 8

  measured using high performance liquid chromatography (HPLC)

  Will occur on day 8 of the study

• Peripheral blood glutamate level, day 10

  measured using high performance liquid chromatography (HPLC)

  Will occur on day 10 of the study

Secondary Outcomes (50)

• Baseline Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale scores

  Will occur on the day of enrollment in the study

• Day 2: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale scores

  Will occur on the day 2 after randomization (if participant has not yet discharged from the hospital)

• Day 3: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale scores

  Will occur on the day 3 after randomization (if participant has not yet discharged from the hospital)

• Day 4: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale scores

  Will occur on the day 4 after randomization (if participant has not yet discharged from the hospital)

• Day 5: Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scale scores

  Will occur on the day 5 after randomization (if participant has not yet discharged from the hospital)

Study Arms (2)

Riboflavin

EXPERIMENTAL

Participants in this group will receive 100mg riboflavin TID during study participation.

Drug: Riboflavin

Placebo

PLACEBO COMPARATOR

Participants in this group will receive inert placebo capsules TID during study participation.

Other: Placebo

Interventions

Riboflavin DRUG

The intervention will consist of 100mg riboflavin (vitamin B2) given in three time daily dosing.

Also known as: Vitamin B2

Riboflavin

Placebo OTHER

An inert, standard placebo in identical capsules to primary intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult veterans ages 18-65
• 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

You may not qualify if:

• Known allergy to ingredients of riboflavin, capsules, or placebo ingredients
• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Nutrition Disorders; Alcoholism

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Brandon Cornejo, MD, PhD

  Oregon Health & Science University, Portland Veterans Health Administration

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Hughes, MD

CONTACT

7014711543; andrew.j.hughes.1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment and placebo capsules will be identical, and will be identified with each participants unique randomization number provided by the VA pharmacy. This will ensure blinding until study completion. Neither participants nor any study or treatment team members will know the group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to receive either riboflavin or an identical inert placebo.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: December 1, 2021
• Primary Completion: August 25, 2022
• Study Completion: October 25, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share