CLINICAL TRIAL

Prazosin for Alcoholism

Recruiting · 18+ · All Sexes · New Haven, CT

This study is evaluating whether a medication may help individuals with alcohol use disorder.

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About the trial for Alcoholism

Eligible Conditions
Substance Withdrawal Syndrome · Alcoholism · Alcohol Withdrawal Syndrome

Treatment Groups

This trial involves 2 different treatments. Prazosin 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 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Prazosin
DRUG
12-Step Facilitation with Relapse Prevention and Contingency Management
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
12-Step Facilitation with Relapse Prevention and Contingency Management
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prazosin
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person does not have any health conditions that would impact their participation in the trial, as verified by screening and physical examination. show original
People who score 3 or higher on the CIWA-Ar questionnaire at treatment entry, and who report regular weekly alcohol use of at least 3 times a week or more, are likely to experience alcohol withdrawal symptoms. show original
Must have a score of 8 or higher on the Alcohol Dependence Scale (ADS) The person must meet the current DSM-5 criteria for moderate to severe Alcohol Use Disorder and must have a score of 8 or higher on the Alcohol Dependence Scale. show original
I can read English and complete study evaluations. show original
Can provide clear, concise information in both written and verbal form. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 12 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 12 weeks.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Prazosin will improve 1 primary outcome and 3 secondary outcomes in patients with Alcoholism. Measurement will happen over the course of up to 12 weeks.

Percent Heavy Drinking Days
UP TO 12 WEEKS
Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women).
UP TO 12 WEEKS
Percent of Subjects with no Heavy Drinking Days
UP TO 12 WEEKS
Prazosin versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.
UP TO 12 WEEKS
Percent Any Drinking Days
UP TO 12 WEEKS
Percent of any drinking days over a 12 week period.
UP TO 12 WEEKS
Average Drinks per Day
UP TO 12 WEEKS
The average number of drinks consumed per day assessed weekly over the treatment period.
UP TO 12 WEEKS

Patient Q & A Section

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

What is alcoholism?

Alcoholism is a common condition that is characterized by drinking to excess of alcohol. It has strong effects on individuals, both physically and mentally. Patients affected by alcoholism experience excessive withdrawal symptoms during alcohol withdrawal. It causes liver and brain damage, and also increases the risk of other serious illnesses. In the USA, 9.7% of men and 5.5% of women are affected by alcoholism. Alcoholism leads to a loss of life and increased medical care. It costs the US economy $147 billion a year, including medical costs, criminal justice system costs, and the cost of lost productivity. Worldwide, it causes about three million premature deaths each year.

Anonymous Patient Answer

What are common treatments for alcoholism?

Overall, almost half of the alcohol-dependent patients surveyed used at least one pharmacotherapeutic approach, and one third of these patients used alcohol replacement therapy. Patients who reported a prior inpatient detoxification were more likely to use alcohol replacement therapy.

Anonymous Patient Answer

What causes alcoholism?

Although there are a number of hypotheses, it appears that both genetic and environmental causes are involved in alcoholism. It is possible that genetics play a role in the early onset of alcoholism. An important environmental factor is alcohol. It appears that drinking alcohol gives people confidence and makes their lives feel better so people end up drinking more and more. On top of that, some people choose alcoholism because friends or family have it and it makes people feel better. To try to reduce the incidence of alcoholism, we need to find ways of educating people about the risk of alcoholism so they can decide more carefully when and how much they drink.

Anonymous Patient Answer

What are the signs of alcoholism?

Alcoholism can first present with headaches, a headacheless episode and dizziness. Then it can progress to dysphoria, irritability, confusion, slurred speech, paranoia, and hallucinations. In extreme cases, dysphoria and hallucinations can manifest as anxiety, aggressiveness, and aggression.

Anonymous Patient Answer

Can alcoholism be cured?

In general, alcoholics can be kept in remission. The remission depends on the seriousness and recurrence of symptoms on admission to the unit. The remission rate also depends on the kind and amount of counseling provided to patients before, during and after admission to the unit.

Anonymous Patient Answer

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

Approximately 12% of men and 3% of women receive a diagnosis of alcoholism within their lifetime. With the use of the US Alcoholics Anonymous (AA) self-help group, more than one-quarter of former drinkers abstain from drinking within the year after initiation. AA affiliation may help to prevent or delay alcohol dependence.

Anonymous Patient Answer

What is prazosin?

All alpha1-adrenoceptor antagonists are effective antihypertensive agents. The selection of alpha1-antagonists may be determined to some extent by clinical experience. However, the clinical significance of any difference between alpha1-blocking and alpha1-blocking agents in the treatment of hypertension remains to be shown. Prazosin and doxazosin are available in different brands in the US.

Anonymous Patient Answer

Who should consider clinical trials for alcoholism?

The evidence for improved or decreased risk of developing alcoholism based on participation in a study is limited, and the results, if they ever achieve statistical significance, will most likely be very different from the results from the study as a whole or from other trial populations. The only study that does provide evidence that a lower prevalence of alcoholism does occur, but the study results were from a population-based study and not from a clinical trial. In light of these findings, the majority of clinicians would consider only symptomatic treatments for alcohol abuse or cessation of drinking for patients at risk for developing alcohol-related adverse outcome events.

Anonymous Patient Answer

What does prazosin usually treat?

Recent findings of this study, which was based on clinical case reports to medical subspecialty clinics, suggest that this drug may be useful for preventing and treating alcohol-induced amathesias, particularly parechovacositis and alcoholic delirium and that the potential use of prazosin for these indications warrants clinical evaluation. These observations are particularly intriguing because alcohol-related deficits can be found in a very large percentage of patients presenting with alcohol amathesias regardless of the presence of chronic alcohol abuse.

Anonymous Patient Answer

Is prazosin safe for people?

The data suggest that prazosin is effective for reducing symptoms associated with alcohol withdrawal at a dose appropriate to an individual's pre-existing medical history and can be a useful adjunct treatment in alcohol-dependent people, helping more people withdraw from alcohol.

Anonymous Patient Answer

Have there been other clinical trials involving prazosin?

The prazosin (PHT) study was one of the first clinical trials performed using a drug class that could alter the progression of the disease. Further, it was the first report to show that prazosin could be used safely and effectively in treatment-resistant patients with alcohol dependence.

Anonymous Patient Answer

What is the primary cause of alcoholism?

Although genetics plays a role in determining our propensity to alcoholism, the environment also plays a major role in alcoholism. Alcoholism's beginnings are not clearly identifiable as either medical or behavioral. Alcoholism can either be physical or behavioral in nature but the mechanism is always related to the interaction of genetics and personal attributes.\n

Anonymous Patient Answer
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