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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

Study Summary

This trial is testing a new way to help people with Alcohol Use Disorder (AUD), by trying to find biomarkers that show if a person will respond to a medication called acamprosate.

Eligible Conditions
  • Alcoholism

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,705 Total Patients Enrolled
8 Trials studying Alcoholism
1,198 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,133 Total Patients Enrolled
422 Trials studying Alcoholism
984,830 Patients Enrolled for Alcoholism
Victor M KarpyakPrincipal InvestigatorMayo Clinic

Media Library

Acamprosate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03818191 — Phase 4
Alcoholism Research Study Groups: Placebo, Acamprosate
Alcoholism Clinical Trial 2023: Acamprosate Highlights & Side Effects. Trial Name: NCT03818191 — Phase 4
Acamprosate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03818191 — Phase 4

Frequently Asked Questions

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

What is the normal therapeutic application of Acamprosate?

"Acamprosate can offer effective treatment for those abstaining from alcohol, enrolled in psychosocial support programs and suffering from dependency issues."

Answered by AI

Has recruitment for this trial been initiated yet?

"Indeed, this medical trial is open for enrollment. It was first posted on July 15th 2019 and experienced its most recent update on September 19th 2022 according to clinicaltrials.gov data."

Answered by AI

Are there any risks associated with Acamprosate usage?

"As it's a Phase 4 trial, Acamprosate has been pre-approved and is thus given an estimated safety rating of 3."

Answered by AI

Are there other clinical investigations that have utilized Acamprosate?

"Currently, two clinical trials concerning the efficacy of Acamprosate are running. One is in Phase 3 and four locations are participating in these studies; most notably Dresden, Sachsen."

Answered by AI

Are individuals aged 25 and above eligible for this clinical experiment?

"Prospective patients must meet the qualifications for enrollment, which stipulate that participants should be between 18 and 85 years of age."

Answered by AI

To what extent is this clinical trial inclusive of participants?

"Correct. On clinicaltrials.gov, it is evident that the trial which opened on July 15th 2019 is still open for participants to join. 800 patients are needed from 3 distinct sites in order to move forward with the study."

Answered by AI

Could I be included in this experiment?

"This research requires 800 alcohol-dependent individuals aged between 18 and 85. Additionally, participants must meet the following conditions: diagnosis of Alcohol Use Disorder (AUD) with PRISM; completion of detoxification via a CIWA score < 5; abstaining from any consumption for at least seven days but not more than 35 days; competent in English; no chronic/daily use of benzodiazepines, opioids or stimulants (prohibiting dose determined by 3x half-life); discontinue previous acamprosate treatment before randomization to study medication (acamprosate or placebo); ability to provide informed consent, willingness to take part"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome
Victor M. Karpyak 2019. "Pharmacogenomics and Pharmacometabolomics of Acamprosate Treatment Outcome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03818191.
~66 spots leftby Apr 2025
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