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Pregabalin plus BBCET for Post-Traumatic Stress Disorder
Study Summary
This trial will study whether pregabalin can help reduce risky drinking and PTSD symptoms in people with certain genes. It will also look at whether pregabalin is safe and well tolerated in this population.
- Post Traumatic Stress Disorder
- Alcoholism
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 57 Patients • NCT02884908Trial Design
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- You have had serious or life-threatening side effects from medications before or during this study.You want to quit drinking alcohol.You are open to participating in therapy to help with post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD).You have a serious medical condition that needs ongoing medical care or close monitoring, or any condition that may interfere with taking topiramate.
- Group 1: Pregabalin + BBCET - NI/I/II type
- Group 2: Pregabalin + BBCET - NI/NI type
- Group 3: Placebo + BBCET - NI/I/II type
- Group 4: Placebo + BBCET - NI/NI type
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Do the elderly have any success with this type of treatment?
"According to the age range delineated in the eligibility requirements, the minimum age for participation is 18 and the maximum is 65."
Are there any current openings for participants in this research project?
"The trial, which was originally posted on September 1st 2016 and updated November 8th 2022, is not looking for participants at this moment. However, 607 other trials are actively recruiting patients."
How many people are involved in this clinical trial?
"Unfortunately, this study is no longer recruiting patients for participation. The original posting date was September 1st, 2016 and the most recent update was on November 8th, 2022. However, there are 586 other trials focused on alcoholism that are currently admitting participants and 21 studies investigating Pregabalin plus BBCET actively recruiting patients."
Could I be a candidate for this particular medical research?
"Up to 252 patients that struggle with alcoholism can participate in this trial, so long as they are between 18-65 years old. There are a few notable requirements for would-be participants, such as being of European or African American descent, providing written informed consent, and having good physical health as determined by a complete physical examination and EKG among other tests."
What medical condition is Pregabalin commonly used in conjunction with BBCET to treat?
"Pregabalin in conjunction with BBCET has shown to be an effective treatment for fibromyalgia, anxiety disorders, and vitamin b12 deficiency."
Is there an increased risk for patients who take Pregabalin and BBCET together?
"Pregabalin plus BBCET is considered safe based on our team's estimation. This assessment comes from the fact that this is a Phase 3 trial, which suggests that not only does some data support efficacy, but multiple rounds of data also support safety."
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