Diclofenac for Alcohol Use Disorder

Phase 1

Waitlist Available

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-65

In the 30-day period before enrollment, consume more than 14 and more than 7 standard drinks per week for men and women, respectively

Must not have

Currently on prescription medication that contraindicates use of diclofenac

Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to the end of session 4 (approximately 5 weeks)

Summary

This trial aims to test whether a medication called diclofenac can increase a specific brain chemical called KYNA in individuals with Alcohol Use Disorder (AUD). This brain chemical plays a role in alcohol-related

Who is the study for?

This trial is for individuals with Alcohol Use Disorder (AUD). Participants will undergo four sessions where they'll receive different doses of Diclofenac or a placebo to see if it affects their craving and mood.

What is being tested?

The study tests whether Diclofenac, at doses of 50mg, 75mg, or 100mg, can increase KYNA levels in the brain and reduce alcohol-related behaviors compared to a placebo in people with AUD.

What are the potential side effects?

Diclofenac may cause side effects like stomach pain, heartburn, nausea, headache, dizziness, liver issues. It's an anti-inflammatory drug so it might also lead to increased bleeding risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I drink more than 14 (if male) or 7 (if female) alcoholic drinks weekly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication that cannot be mixed with diclofenac.

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I am taking medication for schizophrenia, bipolar disorder, or similar conditions.

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I am not pregnant, nursing, or willing to use birth control if I can have children.

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I tested positive for COVID-19 and had symptoms in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to the end of session 4 (approximately 5 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to the end of session 4 (approximately 5 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the end of session 4 (approximately 5 weeks) for reporting.