Study Summary
This triallooks into the effects of taking GABA to improve sleep quality & chronic pain in older adults, to better understand the related neurobiology.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Baseline up to 1 month
Month 1
Self-Reported Sleep Quality Scoring
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Daily Oral GABA
1 of 2
Daily Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
198 Total Participants · 2 Treatment Groups
Primary Treatment: GABA · Has Placebo Group · Phase 2
Daily Oral GABA
DietarySupplement
Experimental Group · 1 Intervention: GABA · Intervention Types: DietarySupplementDaily Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GABA
2019
N/A
~220
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 1 month
Who is running the clinical trial?
University of FloridaLead Sponsor
1,262 Previous Clinical Trials
699,312 Total Patients Enrolled
12 Trials studying Chronic Pain
2,141 Patients Enrolled for Chronic Pain
National Institute on Aging (NIA)NIH
1,448 Previous Clinical Trials
4,279,302 Total Patients Enrolled
11 Trials studying Chronic Pain
1,473 Patients Enrolled for Chronic Pain
Thorne Research Inc.Industry Sponsor
10 Previous Clinical Trials
413 Total Patients Enrolled
Yenisel Cruz-Almeida, MSPH, PhDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
325 Total Patients Enrolled
1 Trials studying Chronic Pain
325 Patients Enrolled for Chronic Pain
Eligibility Criteria
Age 65 - 100 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are at least 45 years old and have had moderate to severe pain on most days for the past 3 months, as well as poor sleep quality.