Acamprosate for Alcoholism

Overseen By Nancy Diazgranados, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Must not be taking: Naltrexone, Disulfiram, Benzodiazepines, others

Disqualifiers: Pregnancy, Head trauma, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 21 days

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how acamprosate, a medication that reduces anxiety and cravings, affects brain function in people with alcohol use disorder (AUD). Participants will take either acamprosate or a placebo for 21 days while researchers monitor their brain activity using EEG, which records electrical activity in the brain. Ideal candidates for this trial are individuals aged 21 to 65 diagnosed with moderate to severe AUD. Participants will remain in the clinic throughout the trial and undergo additional brain and sleep studies. As a Phase 4 trial, this research seeks to understand how the FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications. The trial excludes individuals who have used naltrexone, disulfiram, benzodiazepines (except Oxazepam), antiepileptic compounds, antidepressants, or neuroleptics within the last 4 weeks.

What is the safety track record for this treatment?

Research has shown that acamprosate is generally safe and well-tolerated. The FDA has already approved it for treating alcohol use disorder. Studies have found that it can help reduce anxiety and cravings in some individuals with this condition. Some people might experience side effects like diarrhea, nervousness, or fatigue, but these are usually mild. One study found that acamprosate may be safe for people with alcohol-related liver disease. Overall, this treatment has a good safety record for those needing help with their alcohol use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Acamprosate is unique because it specifically targets the brain's chemical balance disrupted by alcohol use disorder. Unlike traditional treatments such as naltrexone and disulfiram, which focus on reducing cravings or causing unpleasant reactions to alcohol, acamprosate works by stabilizing neurotransmitter systems, particularly glutamate and GABA. This novel approach may help in maintaining abstinence by addressing the neurological imbalances that contribute to alcohol dependence. Researchers are excited about acamprosate because it offers a different pathway to support recovery, potentially improving long-term outcomes for individuals struggling with alcoholism.

What is the effectiveness track record for acamprosate in treating alcoholism?

Research has shown that acamprosate, which participants in this trial may receive, effectively helps people with alcohol dependence. Studies have found that it helps individuals stay sober longer than those taking a placebo, a pill with no active medicine. Those taking acamprosate have a lower risk of drinking again. It reduces cravings and anxiety, which can hinder sobriety. Although its effects are moderate, acamprosate consistently outperforms no treatment, making it a valuable option for managing alcohol use disorder. ^{2 5 6 7 8}

Who Is on the Research Team?

Nancy Diazgranados, M.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Are You a Good Fit for This Trial?

This trial is for people aged 21 to 65 with moderate to severe alcohol use disorder (AUD). Participants will be required to stay in the clinic for a period after detox and must not know which treatment they are receiving.

Inclusion Criteria

I am between 21 and 65 years old.

Not consume alcohol which is also a requirement for the NIH Clinical Center as they are inpatients seeking treatment for AUD

Enrolled in NIAAA natural history protocol 14-AA-0181

Exclusion Criteria

I have had a head injury that knocked me out for over 30 minutes or required brain surgery.

I have a history of epilepsy.

I am not allergic to acamprosate and my kidneys work well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Detoxification

Participants undergo a detoxification period before starting the main treatment

7 days

Treatment

Participants receive either acamprosate or placebo for 21 days as inpatients

21 days

Daily monitoring as inpatients

Follow-up

Participants are monitored for safety and effectiveness after treatment, including optional EEG and sleep studies

6 months

Up to 3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acamprosate

Trial Overview

The study tests Acamprosate, an FDA-approved drug that may reduce anxiety and craving in AUD patients. It's compared against a placebo. The effects on brain function are monitored using EEG while participants perform specific tasks.

How Is the Trial Designed?

Group I: Active Active Control 1 Intervention

This arm has participants receiving acamprosate for 21 day as inpatients.

Group II: Placebo Placebo Group 1 Intervention

This arm has participants receiving placebo for 21 day as inpatients.

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Acamprosate, when used alongside psychosocial treatment, is effective in helping alcohol-dependent patients maintain abstinence, as shown in a review of 13 clinical trials involving 4234 participants.

The treatment is generally safe, with mild to moderate side effects like diarrhea and flatulence, and it can be used in patients with liver issues, although a dose reduction is advised for those with kidney problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acamprosate: safety and tolerability in the treatment of alcohol dependence. Rosenthal, RN., Gage, A., Perhach, JL., et al.[2011]

A meta-analysis of 22 studies involving 1,317 women and 4,794 men found that acamprosate significantly improves abstinence rates and reduces heavy drinking days in both sexes, with a notable increase in treatment completion and medication compliance compared to placebo.

There were no significant differences in efficacy, safety, or tolerability of acamprosate between men and women, indicating that both genders can benefit equally from this treatment for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acamprosate for alcohol dependence: a sex-specific meta-analysis based on individual patient data. Mason, BJ., Lehert, P.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3277871/

Acamprosate for treatment of alcohol dependence

Acamprosate has been shown to be an effective medication in the treatment of alcohol dependence. However, the effects of acamprosate are only moderate in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3565569/

Safety and Efficacy of Acamprosate for the Treatment of ...

The results revealed that acamprosate was superior to placebo in both cumulative abstinence days and in rates of abstinence (in contrast to the COMBINE study), ...

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2811435

Pharmacotherapy for Alcohol Use Disorder: A Systematic ...

The numbers needed to treat to prevent 1 person from returning to any drinking were 11 (95% CI, 1-32) for acamprosate and 18 (95% CI, 4-32) for ...

4.

aafp.org

aafp.org/pubs/afp/issues/2011/0301/p522.html

Effectiveness of Acamprosate in the Treatment of Alcohol ...

Among patients taking acamprosate in the 24 trials, risk of return to any drinking was 86 percent that of patients treated with placebo (i.e., ...

5.

ejinme.com

ejinme.com/article/S0953-6205(22)00194-7/fulltext

Perspectives on the pharmacological management of ...

Studies that took place in the 80 s have shown the efficacy of acamprosate in both reducing alcohol intake and in maintaining abstinence. The ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06471686?term=AREA%5BInterventionSearch%5D(%22Acamprosate%22)&rank=10

Safety of Acamprosate in Treating Alcohol Use Disorder ...

The primary outcome was safety [prevalence of adverse events (AE)]. Secondary outcomes included feasibility (weekly survey response rate >60%), adherence (self ...

7.

mayoclinicproceedings.org

mayoclinicproceedings.org/article/S0025-6196(24)00686-4/abstract

Safety of Acamprosate in Patients With Alcohol-Associated ...

Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy ...

8.

uptodate.com

uptodate.com/contents/alcohol-use-disorder-pharmacologic-management

Alcohol use disorder: Pharmacologic management - UpToDate

Adverse effects – The most prominent adverse effects of treatment with acamprosate include diarrhea, nervousness, and fatigue.