Topiramate for Alcoholism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, PA
Alcoholism+2 More
Topiramate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication may help African American veterans with alcohol use disorder.

See full description

Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Topiramate will improve 1 primary outcome in patients with Alcoholism. Measurement will happen over the course of 12 weeks.

12 weeks
Percent days of heavy drinking

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Topiramate
Paraesthesia
31%
Cognitive Disorder
13%
Nausea
13%
Fatigue
13%
Dizziness
13%
Decreased appetite
11%
Vision blurred
8%
Distubance in attention
8%
Sinusitis
7%
Depression
6%
Concussion
1%
Chronic obstructive pulmonary disease
1%
Peripheral arterial occlusive disease
1%
Nephrolithiasis
1%
Pneumonia
1%
Road traffic accident
1%
Deep vein thrombosis
1%
Dehydration
1%
Atrial tachycardia
0%
Syncope
0%
Invasive lobular breast carcinoma
0%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT02191579) in the Topiramate ARM group. Side effects include: Paraesthesia with 31%, Cognitive Disorder with 13%, Nausea with 13%, Fatigue with 13%, Dizziness with 13%.

Trial Design

2 Treatment Groups

Topiramate
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 160 total participants across 2 different treatment groups

This trial involves 2 different treatments. Topiramate 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.

Topiramate
Drug
Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.
Placebo
Drug
a placebo control arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topiramate
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 weeks for reporting.

Closest Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
self-identification as African American;
age 18 to 70 years, inclusive;
average weekly ethanol consumption of >24 standard drinks for men or >18 standard drinks for women, with a weekly average of > 2 heavy drinking days (men: > 5 standard drinks; women: > 4 standard drinks) during the month before screening;
a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
expressed goal to reduce or stop drinking;
able to read English at the 6th grade or higher level and without gross cognitive impairment;
women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment
willing and able to provide signed, informed consent to participate in the study.

Patient Q&A Section

Does alcohol drinking run in families?

"Alcohol is the most important risk factor for the progression from heavy alcohol consumption to alcoholism. However, the family history for this disorder does not seem to be an independent risk factor in these families." - Anonymous Online Contributor

Unverified Answer

What are the signs of alcohol drinking?

"Alcohol can lead to headaches; trouble sleeping and restlessness; dizziness; blurred vision; sore tongue, dizziness and nausea; loss of balance and feeling tired; and confusion. Long-term heavy drinking can lead to the development of an alcohol-induced liver disease called [alcoholic liver failure (ALD)] (a type of cirrhosis). Alcohol-induced liver disease is rare but can be life-threatening." - Anonymous Online Contributor

Unverified Answer

What causes alcohol drinking?

"Alcohol drinking is primarily related to peer pressure, curiosity, and fun. Alcohol consumption is correlated with certain peer groups; alcohol drinkers tend to associate with other drinkers." - Anonymous Online Contributor

Unverified Answer

How many people get alcohol drinking a year in the United States?

"Alcohol is the single most widely used drug in America among both men and women. About 12 billion alcoholic beverages are consumed each year in the United States, or around 8% of U.S. fluid consumption." - Anonymous Online Contributor

Unverified Answer

Can alcohol drinking be cured?

"We show a strong association between alcoholism and an increased risk for developing prostate cancer. Drinking > 10 drinks/day for > 5 years increased the risk by three-fold compared to a nondrinking men." - Anonymous Online Contributor

Unverified Answer

What are common treatments for alcohol drinking?

"Alcohol drinking is a highly widespread and common behavioural problem and is treated with the same general principles used for other addictive behaviours. Treatment should first aim to reduce the number of drinks, then to reduce the frequency (drinking on a daily basis), and finally to help those with drinking problems to develop and use skills for coping with their drinking. Attention should also be paid to managing co-occurring mental health difficulties, particularly depression." - Anonymous Online Contributor

Unverified Answer

What is alcohol drinking?

"Alcohol drinking is a high risk behavior that can impact personal health. A number of research studies found that it is positively related to many types of mental disorders, such as depression, anxiety, and personality disorders. Furthermore; the negative consequences of alcohol drinking are very widespread as shown by the increase in incidence of alcoholic liver disease and many forms of cancers (cancer of the oral cavity, pancreatic cancer, non-Hodgkin's lymphoma, colorectal cancer, breast cancer, esophageal cancer, larynx cancer, and pharynx cancer, hepatic cancer, gastro-intestinal cancer, urinary bladder cancer, prostate cancer and many, many others)." - Anonymous Online Contributor

Unverified Answer

Is topiramate typically used in combination with any other treatments?

"The vast majority of patients receiving LTG had experienced a withdrawal from topiramate, the most common reasons being rebound effects (72%), headache (56%), gastrointestinal side effects (55%), and dizziness (33%). In contrast to this, only 20% of patients on LTG were discontinued due to side effects. Patients receiving topiramate in combination with other treatments were no more likely to withdraw from LTG or discontinue treatment due to side effects than patients receiving LTG alone." - Anonymous Online Contributor

Unverified Answer

What does topiramate usually treat?

"Topiramate may help people who are experiencing trouble concentrating in the classroom, when being interviewed for employment, or when driving or operating machinery where they have a high likelihood of making a dangerous error. For many students, topiramate may be useful for managing seizures. It may also be useful to prevent seizures for some people who are not having seizures, because this can decrease the chance that they will do something that puts them at risk for a seizure. It may also help people with alcohol or other drug problems. Topiramate may help people who have trouble controlling behavior of their body's natural emotions such as anger, jealousy, or sadness." - Anonymous Online Contributor

Unverified Answer

Has topiramate proven to be more effective than a placebo?

"In the present data, topirotin had a significant efficacy compared with the placebo. In a recent study, findings supports the recent proposal to use topirotin in the treatment of alcohol withdrawal." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets alcohol drinking?

"Alcohol-related diseases can also affect teenagers. So, health care professionals and those who are parenting teenagers are important for educating them on the risks of alcohol. There are many different types of [alcohol-related diseases|alcoholics]. Drinking alcohol in a safe and healthy way is an important thing. Drinking alcohol, and in particular binge drinking, can cause alcohol related health problems." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in topiramate for therapeutic use?

"The recent developments in the development of topiramate were discussed to include recent clinical trials of the drug, the advancement of mechanistic studies, new clinical trials for epilepsy, psychiatric disorders and neuroprotection, and recent trials in mood disorders. Current evidence supporting its use in sleep disorders is weak. Topiramate was evaluated in an open-label study of patients with cognitive dysfunctions associated with alcohol abuse, an area where additional research has been warranted. Overall, most trials have shown a modest efficacy for topiramate in cognitive impairment in alcohol abusers. Clinicians should consider an individualized treatment plan based on the patient’s symptoms, alcohol use history, and the patient’s preference." - Anonymous Online Contributor

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