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Acamprosate for Alcoholism
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
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
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
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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,067 Total Patients Enrolled
8 Trials studying Alcoholism
1,198 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
823 Previous Clinical Trials
1,160,928 Total Patients Enrolled
432 Trials studying Alcoholism
778,089 Patients Enrolled for Alcoholism
Victor M KarpyakPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic or have a strong sensitivity to acamprosate.You are currently taking Wellbutrin and are not willing to switch to another antidepressant that is considered acceptable for the study.You are currently taking Antabuse medication.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Acamprosate
Awards:
This trial has 4 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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