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Amino Acid Supplement
GABA for Chronic Pain (LAMPS Trial)
Phase 2
Waitlist Available
Led By Yenisel Cruz-Almeida, MSPH, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Currently taking barbiturate and benzodiazepine and baclofen
Major medical surgery in the past two months, history of brain surgery or any serious brain condition like aneurysm, stroke, or seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month
Summary
This trial tests whether taking GABA pills can help older adults who have chronic pain and trouble sleeping. GABA is a natural substance that calms the brain and nerves. The goal is to see if it can reduce pain and improve sleep quality in this group. Similar substances have been shown to improve pain and sleep quality in various conditions.
Who is the study for?
This trial is for older adults aged 45 or above who have been dealing with moderate to severe chronic pain and poor sleep quality for the past three months. Participants should not have serious psychiatric conditions, be taking certain medications (like sleep aids or narcotics), or have major systemic diseases. They also shouldn't be pregnant, have metal implants that affect MRI scans, or allergies to GABA.
What is being tested?
The study aims to test whether GABA can improve sleep quality and reduce pain in older adults with chronic pain and sleep issues. It involves comparing the effects of oral GABA against a placebo in a controlled environment to understand its potential benefits and underlying mechanisms.
What are the potential side effects?
While not explicitly stated, possible side effects of GABA may include digestive discomfort, drowsiness, muscle weakness, and allergic reactions. The placebo is unlikely to cause side effects but could include symptoms due to no active treatment being received.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking barbiturate, benzodiazepine, and baclofen.
Select...
I haven't had major surgery, brain surgery, or serious brain conditions in the last 2 months.
Select...
I am unable to give consent for this study.
Select...
I have low blood pressure.
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I do not have Alzheimer's, Parkinson's, Epilepsy, or other brain conditions.
Select...
I am taking medication for nerve pain, such as anticonvulsants or antidepressants.
Select...
I take sleep medications like Ambien or Lunesta.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Self-Reported Sleep Quality Scoring
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Daily Oral GABAExperimental Treatment1 Intervention
You will take, by mouth, 2 pills of GABA (500 mg) (Capsule 250mg) daily at home for 4 weeks
Group II: Daily PlaceboPlacebo Group1 Intervention
You will take, by mouth, 2 pills of Placebo daily at home for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GABA
2021
Completed Phase 2
~240
Find a Location
Who is running the clinical trial?
Thorne Research Inc.Industry Sponsor
10 Previous Clinical Trials
426 Total Patients Enrolled
University of FloridaLead Sponsor
1,393 Previous Clinical Trials
766,996 Total Patients Enrolled
17 Trials studying Chronic Pain
3,384 Patients Enrolled for Chronic Pain
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,184,065 Total Patients Enrolled
17 Trials studying Chronic Pain
2,256 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking barbiturate, benzodiazepine, and baclofen.I am unable to give consent for this study.You have severe mental health conditions like schizophrenia, major depression, or bipolar disorder.I haven't had major surgery, brain surgery, or serious brain conditions in the last 2 months.I have low blood pressure.I do not have Alzheimer's, Parkinson's, Epilepsy, or other brain conditions.I am taking medication for nerve pain, such as anticonvulsants or antidepressants.I have a disease affecting my digestive system.I take sleep medications like Ambien or Lunesta.You were hospitalized for mental health reasons in the last year.You have significant problems with memory and thinking, as shown by a specific test score.You are currently using narcotic medications for a long time.You are very worried about following the study's instructions.My cancer is either active, or I've been in remission for less than two years.I do not have uncontrolled diabetes, high blood pressure, or serious rheumatic diseases.You have a history of alcohol or drug abuse.You are allergic to GABA or any of the ingredients in the study drug, or to the placebo or any of its ingredients.I am over 45, have had moderate to severe pain most days for the last 3 months, and my sleep quality is poor.
Research Study Groups:
This trial has the following groups:- Group 1: Daily Oral GABA
- Group 2: Daily Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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