Pregabalin plus BBCET for Alcoholism

2
Effectiveness
3
Safety
University of Maryland School of Medicine, Baltimore, MD
Alcoholism+2 More
Pregabalin plus BBCET - Drug
Eligibility
18+
All Sexes
Eligible conditions
Alcoholism

Study Summary

This study is evaluating whether a drug may help reduce risky drinking and symptoms of posttraumatic stress disorder.

See full description

Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorders (AUD)
  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Estimate

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

Study Objectives

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.

90 days
Drinking variables as measured by the Time Line Follow Back (TLFB)
PTSD Cluster B symptoms as measured by the CAPS-5
PTSD Cluster B symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)
PTSD Cluster E symptoms as measured by the CAPS-5
PTSD total symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5)

Trial Safety

Safety Estimate

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

Trial Design

4 Treatment Groups

Placebo + BBCET - NI/I/II type
Pregabalin + BBCET - NI/I/II type
Placebo group

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.

Pregabalin + BBCET - NI/I/II type
Drug
This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET).
Pregabalin + BBCET - NI/NI type
Drug
This group will be comprised of subjects with the NI/NI type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET).
Placebo + BBCET - NI/I/II type
Other
This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET).
Placebo + BBCET - NI/NI type
Other
This group will be comprised of subjects with the NI/NI type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 90 days for reporting.

Who is running the study

Principal Investigator
M. B.
Prof. Melanie Bennett, Professor
University of Maryland, Baltimore

Closest Location

University of Maryland School of Medicine - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Alcoholism or one of the other 2 conditions listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Males and females of self-reported European or African American ancestry who have given written informed consent
Age 18 to 65 years and weighing within 30% of their ideal body weight (Metropolitan Life Tables). Also, subjects must weigh at least 40 kg and no more than 155 kg.
Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters (see

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?

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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.

Unverified Answer

What causes alcoholism?

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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.

Unverified Answer

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

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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.

Unverified Answer

What are the signs of alcoholism?

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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.

Unverified Answer

Can alcoholism be cured?

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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.

Unverified Answer

What are common treatments for alcoholism?

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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.

Unverified Answer

Is pregabalin plus bbcet safe for people?

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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.

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What are the common side effects of pregabalin plus bbcet?

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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.

Unverified Answer

Have there been other clinical trials involving pregabalin plus bbcet?

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[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.

Unverified Answer

How serious can alcoholism be?

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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.

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What is pregabalin plus bbcet?

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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.

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