Acamprosate for Alcoholism

Overseen By Reza Momenan, Ph.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

Trial Summary

What is the purpose of this trial?

Background: Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD. Objective: To learn more about how acamprosate affects brain function in people with AUD. Eligibility: People aged 21 to 65 years with moderate to severe AUD. Design: Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days. Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking. Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones. Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep. Participants may have up to three follow-up visits for 6 months.

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 data supports the effectiveness of the drug Acamprosate for treating alcoholism?

Research shows that Acamprosate can help reduce the craving for alcohol and support abstinence in people with alcohol dependence. It is more effective when combined with psychosocial treatments, although it may not work for everyone. ^{1 2 3 4 5}

Is acamprosate safe for humans?

Acamprosate has been shown to have an excellent safety and tolerability profile in multiple clinical trials for alcohol dependence, with a similar rate of side effects as a placebo. It is not metabolized by the liver, making it safe for people with liver disease, and it can be used even if alcohol is still being consumed. ^{6 7 8 9 10}

How does the drug Acamprosate differ from other treatments for alcoholism?

Acamprosate is unique because it helps maintain abstinence by balancing brain chemicals affected by alcohol, and it can be used safely in patients with liver issues, unlike some other treatments. It is not metabolized by the liver and is not affected by alcohol use, making it suitable for those who continue drinking or have liver disease. ^{7 9 11 12 13}

Research Team

Reza Momenan, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Predictors of acamprosate efficacy: results from a pooled analysis of seven European trials including 1485 alcohol-dependent patients. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Does psychosocial treatment enhance the efficacy of acamprosate in patients with alcohol problems? [2019]

4. England pubmed.ncbi.nlm.nih.gov

The pharmacological treatment of alcohol dependence: needs and possibilities. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The pharmacological treatment of alcohol dependence: needs and possibilities. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Acamprosate: safety and tolerability in the treatment of alcohol dependence. [2011]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Acamprosate for treatment of alcohol dependence: mechanisms, efficacy, and clinical utility. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Acamprosate in the treatment of alcohol dependence. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Acamprosate in the treatment of alcohol dependence: clinical and economic considerations. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Acamprosate for the treatment of alcohol dependence: a review of double-blind, placebo-controlled trials. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Effects of acamprosate on ethanol-seeking and self-administration in the rat. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. [2018]