This trial is evaluating whether Pregabalin plus BBCET will improve 5 primary outcomes in patients with Alcoholism. Measurement will happen over the course of 90 days.
This trial requires 252 total participants across 4 different treatment groups
This trial involves 4 different treatments. Pregabalin Plus BBCET is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.
Alcoholism is a disease that causes tolerance, loss of control, emotional dependence, and the craving for alcohol. The disease is often detected between the ages of 20 and 40 and there are several subtypes that tend to be more prevalent in males than in females. It often begins in early adulthood, but its severity and duration can vary. The disease is characterized by an alcoholic personality and can devastate an alcoholic's personal, occupational, and social life, as well as negatively impact the welfare of those around the alcoholic.
Alcoholism is a complex disorder caused by gene-environment interaction. It is difficult to pinpoint the exact cause, as the environment is known to be an important factor in the development of alcohol abuse and addiction. The major risk factors are related to unhealthy weight loss, nicotine addiction, alcohol dependence and drug addiction, or a combination thereof. Some other factors, such as alcoholism in certain ethnic groups, may also be genetically related or be due to a common causal mechanism. Although genetics plays a major role in alcoholism, environmental factors have an equally important yet not adequately studied impact on the disorder.
Alcoholism has been present since time immemorial; however, the amount and extent of alcohol consumption can dramatically change over time. This report describes the changes in alcohol prevalence in the United States from 1997-2014 to describe and provide insight into the alcohol trajectory. Alcohol consumption remained the number 1 problem, but the number of people who were diagnosed with serious alcohol and substance use problems (i.e., dependence or abuse) increased significantly. This change is thought to be related to social, economic, and psychological factors in our society.
Alcoholism is a highly prevalent and deadly disease. People with binge drinking are at an increased risk of alcoholism. People with alcohol-related problems are more likely to be older and to be of lower socioeconomic status. Alcohol-induced liver disease is the most common cause of deaths in alcoholics.
The study provides preliminary evidence of decreased drinking among the population of subjects who received the treatment program versus control groups. The lack of difference in alcohol dependence scores across groups and lack of an effect-size that could support the proposal for treatment are discussed, concluding that it is premature to speculate whether alcohol treatment can effectively alter alcohol use. Further studies are needed to test and generalize these findings.
There are a multitude of psychotherapy approaches, though the evidence supporting them is not compelling. There are a few treatments with evidence supporting their efficacy, but in general, there is a paucity of evidence for the most common treatments. At this time, there is not one empirically supported treatment that is universally effective across all cases of alcoholism.
Results from a recent paper for newly hospitalized patients with alcohol dependence or alcohol withdrawal, prescribing gabapentin with buccomedial bbcet resulted in similar adverse events as in patients prescribed gabapentin alone. Results from a recent paper suggest that gabapentin plus buccomedial bbcet is well-tolerated for opioid-exposed alcohol dependence and/or withdrawal patients.
Pregabalin is safe in combination with bbcet, as it is generally well tolerated especially in older adults. One in 10 subjects (10%) reported headaches, dizziness, dry mouth, and ataxia. In our center, it appears that less than a third of the patients had to be treated permanently due to side effects.
[Bbcet is an analgesic or analgesic/anti-inflammatory drug marketed by The United Kingdom National Health Service (NHS): https://www.health.gov.uk/healthvidues/vidlink.php?vid=1&nhssn=10; a similar drug, pregabalin, has also been studied in clinical trials in Australia involving a combination with the analgesic tramadol:https://www.gov.
Data from a recent study has shown a significant amount of alcohol-related problems and the need for intervention among female drinkers. Alcohol use is the single factor that predicts alcohol dependence and alcoholism. Data from a recent study provides evidence that alcoholism in women is as serious as it is in men because of its negative consequences and the needs for intervention.
pregabalin plus bbcet can significantly improve the therapeutic effect relative to pregabalin alone and be well tolerated in patients with alcohol dependence. In this scenario, pregabalin plus bbcet is feasible and could become a useful complementary add-on therapy. pregabalin + bbcet has good potential for developing into new medications by increasing the efficacy of treatment.