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Corticosteroid

Spironolactone for Alcoholism

Phase 1
Recruiting
Led By Lorenzo Leggio, M.D.
Research Sponsored by National Institute on Drug Abuse (NIDA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 hours after oral alcohol administration
Awards & highlights

Study Summary

This trial tests a medicine to help reduce alcohol use in people with AUD. Participants will take the medicine twice a day for 5 days, then drink alcohol in a bar-like setting. Tests include DEXA scan, blood tests, ECG, urine tests, questionnaires & tasks.

Who is the study for?
Adults aged 21+ with Alcohol Use Disorder who drink heavily are eligible for this trial. They must be in good general health, not pregnant or breastfeeding, and using effective birth control if applicable. Participants cannot have certain medical conditions like heart failure or unstable mental health issues, nor can they be on specific medications that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing Spironolactone, a drug normally used for blood pressure and heart failure, to see if it helps people with AUD drink less alcohol. Participants will stay at a clinic multiple times taking either Spironolactone or a placebo without knowing which one they're getting. They'll also undergo tests and answer questions about their alcohol use.See study design
What are the potential side effects?
Spironolactone may cause side effects such as changes in electrolyte levels (like potassium), dehydration symptoms due to its diuretic effect (increased urination), dizziness from low blood pressure, breast tenderness/enlargement in men (gynecomastia), menstrual irregularities in women, and possible gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 hours after oral alcohol administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours after oral alcohol administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Describe alcohol PK during concomitant spironolactone use
Describe steady-state PK of spironolactone in individuals with AUD, before and after oral alcohol administration.
Secondary outcome measures
Describe steady-state PK of spironolactone metabolites in individuals with AUD, before and after alcohol administration
Determine safety, tolerability, and potential drug-alcohol interaction by administering spironolactone, combined with alcohol, in individuals with AUD
Determine whether spironolactone alters subjective and cognitive effects of acute alcohol administration

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo 4th visitExperimental Treatment2 Interventions
Stage1: 2x50 mg/day spironolactoneStage 2: 2x100 mg/day spironolactonestage 3: 2x200 mg/day spironolactonestage 4: Placebo
Group II: Placebo 3rd visitExperimental Treatment2 Interventions
stage1: 2x50 mg/day spironolactonestage 2: 2x100 mg/day spironolactonestage 3: Placebostage4: 2x200 mg/day spironolactone
Group III: Placebo 2nd visitExperimental Treatment2 Interventions
stage 1: 2x50 mg/day spironolactonestage 2: Placebostage3: 2x100 mg/day spironolactonestage 4: 2x200 mg/day spironolactone
Group IV: Placebo 1st visitExperimental Treatment2 Interventions
stage 1: Placebostage 2: 2x50 mg/day spironolactonestage 3: 2x100 mg/day spironolactonestage4: 2x200 mg/day spironolactone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
2005
Completed Phase 4
~7340

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)Lead Sponsor
2,470 Previous Clinical Trials
2,619,711 Total Patients Enrolled
48 Trials studying Alcoholism
28,383 Patients Enrolled for Alcoholism
Lorenzo Leggio, M.D.Principal InvestigatorNational Institute on Drug Abuse (NIDA)
10 Previous Clinical Trials
9,404 Total Patients Enrolled
8 Trials studying Alcoholism
253 Patients Enrolled for Alcoholism

Media Library

Spironolactone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05807139 — Phase 1
Alcoholism Research Study Groups: Placebo 1st visit, Placebo 2nd visit, Placebo 3rd visit, Placebo 4th visit
Alcoholism Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT05807139 — Phase 1
Spironolactone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05807139 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research program open to individuals under 45 years of age?

"Adherence to the set standards for this research project entails participants being between 21 and 99 years old."

Answered by AI

To what extent can 1 be detrimental to a patient's health?

"The risk level associated with this Phase 1 trial is assessed as a score of 1 due to limited evidence validating its efficacy and safety."

Answered by AI

To whom is participation in this investigation accessible?

"To be suitable for inclusion in this clinical study, individuals must suffer from alcohol addiction and have an age between 21 to 99. 20 total volunteers are required for the trial."

Answered by AI

Is enrollment now open for this experiment?

"Clinicaltrials.gov records reveal that this trial, which was posted on April 6th 2023 and updated lastly on the 10th of same month, is no longer recruiting participants; however there are over a thousand other clinical trials open to enrolment at present."

Answered by AI

Who else is applying?

What site did they apply to?
National Institute on Drug Abuse
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Spironolactone in Alcohol Use Disorder (SAUD)
2023. "Spironolactone in Alcohol Use Disorder (SAUD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807139.
~6 spots leftby Aug 2024
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