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Amino Acid Supplement
GABA for Chronic Pain (LAMPS Trial)
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 1 month
Awards & highlights
LAMPS Trial Summary
This triallooks into the effects of taking GABA to improve sleep quality & chronic pain in older adults, to better understand the related neurobiology.
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.Check my eligibility
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.See study design
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.
LAMPS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-Reported Sleep Quality Scoring
LAMPS 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
2019
N/A
~220
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
1,341 Previous Clinical Trials
715,433 Total Patients Enrolled
13 Trials studying Chronic Pain
2,056 Patients Enrolled for Chronic Pain
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,651 Total Patients Enrolled
16 Trials studying Chronic Pain
2,101 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What site did they apply to?
University of Florida
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- University of Florida: < 24 hours
Typically responds via
Phone Call
Average response time
- < 1 Day
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