Treatment for Alcoholism

Phase-Based Estimates
3
Effectiveness
3
Safety
Hazelden Betty Ford Foundation, Center City, MN
Alcoholism+1 More
Eligibility
18+
All Sexes
Eligible conditions
Alcoholism

Study Summary

This study is evaluating whether a metabolite in the urine may predict whether a medication will help prevent relapse to alcohol use.

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Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 secondary outcome in patients with Alcoholism. Measurement will happen over the course of The number of days until first alcohol use assessed by TLFB during 3 months of treatment.

Month 3
Alcohol Timeline Follow Back

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo
Placebo group

This trial requires 800 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the number of days until first alcohol use assessed by tlfb during 3 months of treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly the number of days until first alcohol use assessed by tlfb during 3 months of treatment for reporting.

Who is running the study

Principal Investigator
V. M. K.
Victor M. Karpyak, Principal Investigator
Mayo Clinic

Closest Location

Hazelden Betty Ford Foundation - Center City, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Alcoholism or the other condition listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 to85; DSM-5 diagnosis of AUD determined by PRISM;
Completion of alcohol detoxification (CIWA score < 5) and no alcohol for at least 7 days (but no more than 35 days);
Ability to provide informed consent
Ability to speak English
Willingness to use the study medications for 3 months and attend follow-up visits.
No chronic/daily use of benzodiazepines, opioids, or stimulants for a period of time which is determined by 3 x the medication half-life value (see addendum A) to be completed before the initiation of study medication (acamprosate or placebo).
Willingness to discontinue previously prescribed acamprosate for a period of at least 3 days before randomization to study medication (acamprosate or placebo).

Patient Q&A Section

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

Can alcoholism be cured?

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At this time, there is no evidence that alcoholism can be treated. With appropriate treatment, many patients, with or without comorbid alcoholism/dependence, achieve long-term sobriety.

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What is alcoholism?

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This article defines alcohol use disorder according to DSM-5 criteria with emphasis on alcoholism, not CVS. Alcohol use disorder represents a spectrum of clinically significant problems of alcohol use. The alcohol use disorder paradigm provides a framework for the recognition and assessment of problem-related disorders of alcohol use and for effective substance abuse prevention and treatment. Diagnosing alcohol use disorder can help determine the appropriate level of clinical and community attention to alcohol-based problems.

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What are the signs of alcoholism?

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These signs of alcoholism include: inability to control drinking, problems with family members, alcohol-related problems, and legal and criminal consequences. [https://www.aamembers.org/signs-of-drinking/what-are-the-signs-of-drinking?show=1. Alcoholism may not be visible on the blood or hair. Alcoholism may not be evident on medical records. If patients have signs of alcoholism, their symptoms may be very mild]\n

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What are common treatments for alcoholism?

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Current treatment of alcoholism is largely dependent on the symptoms and severity of the disease and can include a variety of different therapies and medications. However, it is also commonly supportive in nature. The American College of Physicians has provided recommendations for optimal treatments for alcoholism. Alcoholics who are suffering from co-morbid diseases such as hepatitis C or HIV are commonly treated with antiviral, and, in some cases medication.\n

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How many people get alcoholism a year in the United States?

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The estimated prevalence of alcoholism in this population was lower than that reported in the majority of studies, but significantly higher than that of alcoholism alone. Alcohol-related causes of morbidity and mortality are underestimated, with alcohol consumption and misuse contributing significantly to deaths and disability. Alcohol is the second-largest contributor to healthcare expenditure in this population, accounting for around 11% of health care expenditure.

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What causes alcoholism?

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Alcoholism is commonly associated with depression, and research has shown that there may be a causal relationship between alcohol and the development of depression. The two disorders may manifest together. Data from a recent study are based on observational and cross-sectional data.

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What is the average age someone gets alcoholism?

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Alcoholism seems to appear earlier in life for AA men and women than the general population. An explanation for this finding could be that the lifetime effects of a substance, and also that substance use in childhood or adolescence can in turn lead to a substance-related disorder.

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Who should consider clinical trials for alcoholism?

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Clinical research trials for alcohol dependence are not widely available in the United States and most patients must receive care outside the clinical research enterprise. Clinical trials often require lengthy periods of exclusion, during which patients are screened for alcohol dependence and treated only. Few patients are enrolled in clinical trials in which they are included in randomized controlled trials.

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What is treatment?

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Alcoholism is primarily treated in the primary care setting, primarily with behavioural counseling and supportive or rehabilitative care, such as detoxification and treatment of comorbidities. However, only a minority of patients with alcohol dependence will eventually need detoxification. It is difficult to predict which treatment interventions would be most effective in reducing alcohol-related problems in a given population or in a single clinical setting. For patients treated at-treatment in specialist clinics, treatment was the least effective method of reducing alcohol problems.

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Have there been other clinical trials involving treatment?

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[As of 2009,] very few of these trials have had long-term follow-up. Thus, the effect of treatment on survival remains unclear.\n\n- Lung cancer"

"Friedrich Ernst Moritz von Schreber\n\nFriedrich Ernst Moritz von Schreber (28 September 1758 – 30 January 1838) () was a German soldier and writer. He was convicted of a number of crimes including attempted buggery and inciting racial hatred. His name and publications were long associated with a body of anti-semitic or racist literature.

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What is the latest research for alcoholism?

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This article examines recent research to determine whether and when alcohol dependence can be prevented or healed. It also discusses the relationship between alcoholism and its many effects.

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What are the latest developments in treatment for therapeutic use?

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There is active research underway to find effective ways to manage alcohol use during liver disease. While there is no cure or definitive way to treat alcohol use in people with liver disease, some promising medications are in early stage development with phase I and preliminary phase II clinical trials, including agents that help reduce alcohol consumption and alcohol induced liver damage. However, the most effective treatment for hepatic alcohol use remains undefined, and further research is necessary before treatment options can be recommended.

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