Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome

Phase 4

Waitlist Available

Led By Victor M Karpyak

Research Sponsored by Mayo Clinic

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 the number of days until first alcohol use assessed by tlfb during 3 months of treatment

Awards & highlights

Approved for 5 Other Conditions

Pivotal Trial

All Individual Drugs Already Approved

Drug Has Already Been Approved

Summary

This trial is investigating the use of acamprosate, a medication that helps reduce cravings for alcohol, in individuals with Alcohol Use Disorders (AUDs). These patients often relapse after treatment, and new methods are needed to help them stay sober. The study aims to find indicators that can predict who will benefit from acamprosate. Acamprosate is a relatively new drug that has been shown to help maintain abstinence in alcohol-dependent patients by reducing cravings.

Eligible Conditions

Alcoholism

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the number of days until first alcohol use assessed by tlfb during 3 months of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the number of days until first alcohol use assessed by tlfb during 3 months of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and the number of days until first alcohol use assessed by tlfb during 3 months of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Alcohol Timeline Follow Back

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AcamprosateActive Control1 Intervention

All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial. The most common side effect associated with acamprosate use is diarrhea, which occurs in approximately 16% of patients. Other frequently occurring side effects include asthenia, nausea, pruritus, and flatulence, headache, abdominal pain, flu syndrome, edema, weight gain, and myalgia.

Group II: PlaceboPlacebo Group1 Intervention

All participants will be randomized to receive acamprosate or placebo in a double-blinded placebo-controlled trial.

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